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					BSE Inquiry Report




Volume 1
Findings and Conclusions
Volume 1
Findings and Conclusions
Terms of Reference, Committee Members and Report Volumes     xiii
A note on the footnotes                                      xiv

Executive Summary of the Report of the Inquiry             xvii
Introduction                                                 xvii
1. Key conclusions                                           xvii
2. The identification of the emergence of BSE               xviii
3. The cause of BSE                                           xix
4. Assessment of risk posed by BSE to humans                   xx
5. Communication of the risk posed by BSE to humans           xxi
6. Measures to eradicate the disease in cattle                xxi
7. Measures to address the risks posed by BSE to humans      xxii
      Slaughter and compensation                             xxii
      Food risks                                            xxiii
8. Medicines                                                 xxiv
9. Cosmetics                                                 xxvi
10. Occupational risk                                       xxvii
11. Other pathways of infection                            xxviii
12. Pollution and waste control                            xxviii
13. The identification of vCJD                             xxviii
14. Victims and their families                               xxix
15. Research                                                  xxx
16. Some general lessons                                     xxxi

1 Introduction                                                 1
Our task                                                       3
The structure of the Report                                    7
Transmissible Spongiform Encephalopathies                     10
Transmission to humans                                        11
The story in a nutshell                                       13
      What happened?                                          13
      Why did it happen?                                      20

2 Setting the context                                        23
The cattle industry                                           23
Slaughterhouses                                               24
Renderers                                                     25
The animal feed industry                                      27    iii
FINDINGS AND CONCLUSIONS


         The meat industry                                              27
         The pharmaceutical industry                                    28
         Other uses of bovine products                                  28
         Government and BSE                                             29
         Handling risk                                                  31
              Risk evaluation                                           31
              Risk management                                           31
              BSE and risk                                              32

         3 The early years, 1986–88                                     33
         Identification of a new disease in cattle                      33
         Restraints on information                                      34
         What was the cause of BSE?                                     36
               The scrapie theory                                       37
         The ruminant feed ban                                          38
               Exports                                                  41
         Human health implications                                      42
               Mr MacGregor’s reaction                                  45
               Sir Donald Acheson’s advice                              46

         4 The Southwood Working Party and other
         scientific advisory committees                                 48
         The Southwood Working Party                                    48
              Epidemiology                                              49
              Risk to humans                                            50
         Other scientific advisory committees                           55
              The Consultative Committee on Research into SEs
              (The Tyrrell Committee)                                   55
              The Spongiform Encephalopathy Advisory Committee (SEAC)   57

         5 The animal health story                                      58
         Ruminant feed ban                                              59
               The first BAB                                            61
               UKASTA’s information about breaches of the ban           62
               Cross-contamination in feedmills                         63
               What went wrong?                                         66
         Introduction of the animal SBO ban                             68
               The voluntary animal SBO ban                             69
               The cat                                                  70
               The pig                                                  71
               The statutory animal SBO ban                             72

iv
                                                                                    CONTENTS


The operation of the statutory animal SBO ban                                  73
      Before the ban                                                           74
      The human SBO Regulations                                                75
      Enforcement                                                              75
      The voluntary animal SBO ban                                             77
      The statutory animal SBO ban                                             77
      Reliance on the voluntary animal SBO ban                                 79
      Reliance on the human SBO ban                                            79
      Knacker’s yards and hunt kennels                                         80
      SBO in transit                                                           81
Responsibility                                                                 81
Monitoring                                                                     82
      Renderers                                                                84
      Slaughterhouses                                                          85
      Knacker’s yards and hunt kennels                                         86
      ‘Cradle to grave’ reviews                                                86
      The truth emerges                                                        86
      The penny drops                                                          87
      The Meat Hygiene Service takes over and a new SBO stain is introduced    88
      More shortcomings revealed                                               88
      The new Order                                                            90
Did the provisions of the animal SBO ban matter?                               92
Why did it take so long?                                                       93
Two fundamental issues                                                         94
Conclusions                                                                    95
Cattle-tracking                                                                96
Breeding                                                                       96

6 Protecting human health                                                     98
Introduction                                                                   98
CJD surveillance                                                               99
      Surveillance recommended by the Southwood Working Party
      and the Tyrrell Committee                                                99
      The CJD Surveillance Unit established                                    99
      How the surveillance system worked                                       99
      PHLS excluded from CJD surveillance                                     100
Slaughter and compensation                                                    101
      Was compensation too low?                                               104
      Ante-mortem inspection                                                  105
      Compensation changed again                                              105
      Unanticipated burdens                                                   105
Introduction of the ban on Specified Bovine Offal (SBO) in human food         106
      Government response to the Southwood Report                             106      v
FINDINGS AND CONCLUSIONS


               The decision to introduce the human SBO ban                       110
               Preparation of the Regulations                                    113
                     Brain, spinal cord, thymus, spleen and tonsils              115
                     Tripe and rennet                                            115
                     Mesenteric fat                                              115
                     Casings                                                     115
                     Calves under 6 months of age                                116
                     Mechanically recovered meat (MRM)                           117
         BSE and human health in 1990                                            121
               Implementation, enforcement and monitoring of the human SBO ban   121
               Bovine brains                                                     122
               Slaughterhouse practices and mechanically recovered meat          123
               Europe and lymphoid tissue                                        126
               Alarms and reassurances                                           127
               The cat                                                           128
               The Agriculture Committee                                         130
               SEAC considers the safety of beef                                 131
               A look ahead                                                      132
         The false peace – 1 January 1991 to 31 March 1995                       133
               Slaughterhouse standards                                          134
               History of the setting up of the Meat Hygiene Service             135
               Monitoring compliance with the SBO Regulations                    136
               MRM on the agenda again                                           137
               The distal ileum of calves                                        137
               Advances in knowledge of BSE                                      139
               Knowledge about dose                                              141
               Two dairy farmers die from CJD                                    141
               Vicky Rimmer                                                      143
         Chinks in the armour – April–December 1995                              143
               Action at last on MRM                                             146
               Cause for concern                                                 147
               Public debate                                                     148
               A campaign of reassurance                                         150
         The final months                                                        151
               Mr Hogg’s questions                                               152
               SEAC’s meetings on 5 January and 1 February 1996                  154
               The storm clouds gather                                           156
               Rumbles of thunder                                                156
               The storm breaks                                                  157
               Postscript                                                        160
               Contingency planning                                              161
               What would contingency planning have achieved?                    164
vi
                                                                                     CONTENTS


7 Medicines and cosmetics                                                      166
Medicines                                                                      166
The medicines licensing system                                                 167
Medical devices                                                                168
Phase 1: the initial response on veterinary medicines                          169
Phase 1: the initial response on human medicines                               170
     The period up to March 1988                                               170
     March–December 1988                                                       171
            Initial action by the CMO and MD                                   171
            The NIBSC discussion                                               171
            Galvanising MD                                                     172
            The paper for the BSC                                              172
            Sir Richard Southwood’s concerns about biologicals                 173
Phase 2: preparing joint guidelines, January–March 1989                        174
     The final draft of the Southwood Report                                   174
     The continuing concern on vaccines                                        176
     CSM and VPC approval and the issue of the guidelines                      176
     Was the action taken adequate?                                            177
            The Southwood message and how it was interpreted                   178
            Were non-binding guidelines appropriate?                           178
            Was the scope of the guidelines adequate?                          178
            Were existing stocks of injected products treated appropriately?   179
Phase 3: implementing the guidelines after March 1989                          181
     The context for handling matters                                          181
     Collecting and analysing the information                                  181
     The SBO ban and pharmaceuticals                                           182
     How the BSEWG operated                                                    183
     First meeting of the BSEWG on 6 September 1989                            183
            The follow-up to the first meeting                                 184
     Second meeting of the BSEWG on 10 January 1990                            185
            The follow-up to the second meeting                                186
     Third meeting of the BSEWG on 4 July 1990                                 186
     Fourth meeting of the BSEWG on 31 October 1990                            187
            Veterinary products                                                187
     Final meeting of the BSEWG in July 1992                                   187
Overview of the way the guidelines were implemented                            188
     Veterinary medicines                                                      188
     Human medicines                                                           189
Research into pharmaceuticals                                                  190
Cosmetics and toiletries                                                       192
     The main products                                                         192
     Regulation                                                                192
                                                                                        vii
FINDINGS AND CONCLUSIONS


               The Tyrrell recommendation on cosmetics                       193
               Was the initial action adequate?                              193
               Was DTI action adequate?                                      194
               Action taken thereafter                                       194
               The adequacy of the response                                  196

         8 Occupational risk                                                 198
         Those at risk                                                       198
               Chronology of occupational safety advice                      198
         ACDP advice to laboratories, medical workers and undertakers        200
               Chronology of drafting of ACDPWG advice                       201
         The issue of guidance to schools about dissecting bovine eyeballs   203
               Chronology of guidance on bovine eyeball dissection           203
         Overview of occupational health                                     205

         9 Potential pathways of infection                                   207
         Consideration of an audit of the uses of cattle tissues             207
              The Tyrrell recommendation                                     207
              Reasons for this outcome                                       210
              Where responsibility lay                                       210

         10 Pollution and waste control                                      212

         11 Wales, Scotland and Northern Ireland                             215
         Wales                                                               216
         Scotland                                                            216
         Northern Ireland                                                    217
         Collective government and working relationships                     218

         12 Science and research                                             219
         Scientific conclusions about BSE                                    219
         Alternative theories                                                222
               The organophosphate theory                                    222
               The autoimmune theory                                         222
         Research                                                            222

         13 What went right and what went wrong?                             226
         A recipe for disaster                                               226
         The identification of the disease and its cause                     227
         The Government’s response                                           228
               Eradication of BSE                                            228
               Possible transmissibility to other animals                    229
viii
                                                                                  CONTENTS


      Possible transmissibility to humans                                   229
Shortcomings and possible reasons for them                                  231
      Was there a conflict of interest in MAFF?                             231
      Other conflicts of interest                                           232
      Perception of risk                                                    232
      Ignorance and failures of communication                               235
      Ignorance of views as to the minimum infective dose for cattle        236
      Ignorance of views as to the minimum infective dose for humans        237
      Ignorance of pathways of infection                                    237
      Failures of communication                                             238
            Between the Southwood Working Party, the Government
            and the public                                                  238
            Between SEAC, the Government and the public                     238
      Lack of rigorous consideration when giving effect to policy           239
      The best being the enemy of the good                                  239
      Inappropriate use of advisory committees                              240
      Administrative structures                                             242
            Interdepartmental structures                                    242
            DH role                                                         243
            Structure within MAFF                                           243
            Chief Medical Officers and Chief Veterinary Officers            244
            Central and local government                                    244
            Central government and the Territorial Departments              246
Individual criticisms: redressing the balance                               246

14 Lessons to be learned                                                    249
Episodes in the BSE story                                                   249
     Lessons from the fact that BSE emerged                                 249
           Commentary                                                       249
           Lessons                                                          250
     Lessons from the transmissions of BSE                                  250
           Commentary                                                       250
           Lessons                                                          250
     Lessons from the spread of the BSE epidemic                            250
           Commentary                                                       250
           Lessons                                                          251
     Lessons from the identification of BSE                                 251
           Commentary                                                       251
           Lessons                                                          251
     Lessons from the consideration of the nature and implications of BSE   252
           Commentary                                                       252
           Lessons                                                          252
     Lessons from the investigation of the cause of BSE                     252      ix
FINDINGS AND CONCLUSIONS


                   Commentary                                                        252
                   Lessons                                                           253
              Lessons from the introduction of the ruminant feed ban                 253
                   Commentary                                                        253
                   Lessons                                                           253
              Lessons from the introduction of slaughter with compensation           254
                   Commentary                                                        254
                   Lessons                                                           254
              Lessons from the Southwood Report                                      254
                   Commentary                                                        254
                   Lessons                                                           254
              Lessons from the introduction of the animal SBO ban                    255
                   Commentary                                                        255
                   Lessons                                                           255
              Lessons from the implementation and enforcement of the
              animal SBO ban                                                         255
                   Commentary                                                        255
                   Lessons                                                           255
              Lessons from the introduction of the human SBO ban                     256
                   Commentary                                                        256
                   Lessons                                                           256
              Lessons from the final months                                          256
                   Commentary                                                        256
                   Lessons                                                           257
              Lessons in respect of Wales, Scotland and Northern Ireland             257
                   Commentary                                                        257
                   Lessons                                                           257
              Lessons from the emergence of vCJD                                     258
                   Commentary                                                        258
                   Lessons                                                           258
              Lessons from the handling of non-food routes of transmission to humans 258
                   Commentary                                                        258
                   Lessons                                                           258
              Lessons from the approach to BSE and medicines                         259
                   Commentary                                                        259
                   Lessons                                                           259
              Lesson from the approach to BSE and cosmetics                          260
                   Commentary                                                        260
                   Lesson                                                            260
              Lesson from the approach to BSE and occupational risk                  260
                   Commentary                                                        260
                   Lesson                                                            260
x             Lesson in relation to pollution and waste control                      260
                                                                           CONTENTS


           Commentary                                                260
           Lesson                                                    260
     Lessons in relation to research                                 261
           Commentary                                                261
           Lessons                                                   261
     The use of scientific advisory committees                       261
           Commentary                                                261
           Lessons                                                   262
     Dealing with uncertainty and the communication of risk          264
           Commentary                                                264
           Lessons                                                   266
     The legislative framework                                       266
           Commentary                                                266
           The problem                                               267
           Power to order the slaughter of animals                   267
           Power to order the destruction of parts of an animal      268
           Power to ban the use of material for specified purposes   269
           Legislative constraints in relation to medicines          270
           Legislative constraints in relation to cosmetics          271
           General constraints of European law                       271
           Lessons                                                   272
     The experience of vCJD victims and their families               272
           Commentary                                                272
           Lessons                                                   273

Annex 1: Procedures adopted by the BSE Inquiry                       275
Thoroughness and openness                                            275
Fairness                                                             278

Annex 2: Individual criticisms                                       280
The early years                                                      280
The Southwood Working Party                                          281
Protection of animal health, 1989–96                                 281
Protection of human health, 1989–96                                  281
Medicines and cosmetics                                              283
Potential pathways of infection                                      284

Glossary                                                             285

Who’s who                                                            289

Index                                                                297
                                                                              xi
FINDINGS AND CONCLUSIONS




xii
                                                                            Terms of Reference, Committee Members and Report Volumes




The BSE Inquiry Terms of Reference

To establish and review the history of the emergence and identification of BSE and
new variant CJD in the United Kingdom, and of the action taken in response to it up
to 20 March 1996; to reach conclusions on the adequacy of that response, taking
into account the state of knowledge at the time; and to report on these matters to the
Minister of Agriculture, Fisheries and Food, the Secretary of State for Health and
the Secretaries of State for Scotland, Wales and Northern Ireland.



The Members of the Committee

Lord Phillips of Worth Matravers, Master of the Rolls
Mrs June Bridgeman CB
Professor Malcolm Ferguson-Smith MBChB, FRCPath, FRCP(Glasg.), FMedSci,
FRSE, FRS



The Volumes of the Report

 1 Findings and Conclusions

 2 Science

 3   The Early Years, 1986–88
 4   The Southwood Working Party, 1988–89
 5   Animal Health, 1989–96
 6   Human Health, 1989–96
 7   Medicines and Cosmetics
 8   Variant CJD
 9   Wales, Scotland and Northern Ireland
10   Economic Impact and International Trade
11   Scientists after Southwood

12   Livestock Farming
13   Industry Processes and Controls
14   Responsibilities for Human and Animal Health
15   Government and Public Administration

16 Reference Material




                                                                                                                                       xiii
      A note on the footnotes
      During the course of its deliberations, the BSE Inquiry published many thousands of documents,
      along with transcripts of its oral hearings. These formed the evidence on which the Inquiry based its
      chronological accounts, discussions and conclusions. When footnotes refer to these sources, they are
      coded according to the Inquiry’s filing system, which can be consulted by the public in two ways:

          •   either through the Public Record Office, which has a copy of all the evidence in electronic
              form on a series of CD-ROMs; or
          •   on the BSE website (www.bseinquiry.gov.uk).

      YB codes: eg, YB88/12.22/4.1

      YB refers to Year Books. These are documents collected in chronological order, year by year.
      They come from a variety of sources, but many of them are letters, memoranda and minutes of
      departmental meetings. For example, the one mentioned above refers to a document dated
      22 December 1988 (YB88/12.22), which is the fourth document filed for that day and,
      specifically, its first page (4.1).

      S codes (written witness statements): eg, S387 Tomlinson para. 6

      A witness statement is written evidence supplied to the Inquiry. In the example above, the ‘S’
      classifies the evidence as a witness statement, and it is number 387, paragraph 6. ‘Tomlinson’ shows
      that it was written by Sir Bernard Tomlinson. When people have sent in more than one witness
      statement, these statements are classified S387, S387A, etc.

      T codes (transcripts of oral hearings): eg, T40 pp. 121–2

      A number of witnesses gave oral evidence to the Inquiry, and the ‘T’ references indicate transcripts
      of the relevant hearings. The example above refers to day 40 of the oral hearings, pages 121–2.

      IBD codes: eg, IBD1 tab 2 para. 5.3.5

      These are Initial Background Documents – a selection of published material that was supplied by the
      Ministry of Agriculture, Fisheries and Food at the start of the Inquiry. The example refers to the first
      file, or ‘bundle’, of such background documents, and to the second document in that bundle. In this
      case, it is the Report of the Southwood Working Party on Bovine Spongiform Encephalopathy,
      paragraph 5.3.5.

      M codes: eg, M29 tab 3

      These are further bulky documents from a variety of sources (‘M’ stands for ‘Materials’). They have
      been filed in series of bundles in the same way as the Initial Background Documents and the other
      series of bundles described below.

      L codes: eg, L3 tab 6

      These refer to legislation (ie, Statutory Instruments – Regulations, Orders, etc – and Acts), which is
      generally available in published form. For convenience the legislation most frequently referred to at
      hearings was filed in a series of L bundles.

      DM codes: eg, DM01

      Documents from the Ministry of Agriculture, Fisheries and Food (MAFF)



xiv
                          TERMS OF REFERENCE, COMMITTEE MEMBERS AND REPORT VOLUMES

DH codes: eg, DH01

Documents from the Department of Health

DW codes: eg, DW01

Documents from the Welsh Office

DS codes: eg, DS01

Documents from the Scottish Office

DN codes: eg, DN01

Documents from Northern Ireland Departments

DO codes: eg, DO01

Documents from other Departments

SEAC codes: eg, SEAC1

Documents relating to the Spongiform Encephalopathy Advisory Committee

FEG codes: eg, FEG1

Documents relating to the Lamming Committee (the Expert Group on Animal Feedingstuffs)

Tyrrell codes: eg, Tyrrell1

Documents relating to the Consultative Committee on Research into Spongiform Encephalopathies
chaired by Dr David Tyrrell




                                                                                                xv
FINDINGS AND CONCLUSIONS




xvi
Executive Summary of the
Report of the Inquiry

Introduction

By our terms of reference, we have been required:

       To establish and review the history of the emergence and identification of
       BSE and variant CJD in the United Kingdom, and of the action taken in
       response to it up to 20 March 1996; to reach conclusions on the adequacy of
       that response, taking into account the state of knowledge at the time; and to
       report on these matters to the Minister of Agriculture, Fisheries and Food,
       the Secretary of State for Health and the Secretaries of State for Scotland,
       Wales and Northern Ireland.

In this Executive Summary, we give an overview of our key findings and
conclusions. We refer to things that went right as well as to some of the errors,
inadequacies and shortcomings that we have identified in the response to BSE. We
do not attempt here to explain or even list all of these. In particular we do not explain
the criticisms of individuals that appear in our Report. These need as a matter of
fairness to be read in their proper context, as we explain at paragraph 30 of this
volume.



1. Key conclusions

   •   BSE has caused a harrowing fatal disease for humans. As we sign this Report
       the number of people dead and thought to be dying stands at over 80, most
       of them young. They and their families have suffered terribly. Families all
       over the UK have been left wondering whether the same fate awaits them.
   •   A vital industry has been dealt a body blow, inflicting misery on tens of
       thousands for whom livestock farming is their way of life. They have seen
       over 170,000 of their animals dying or having to be destroyed, and the
       precautionary slaughter and destruction within the United Kingdom of very
       many more.
   •   BSE developed into an epidemic as a consequence of an intensive farming
       practice – the recycling of animal protein in ruminant feed. This practice,
       unchallenged over decades, proved a recipe for disaster.
   •   In the years up to March 1996 most of those responsible for responding to
       the challenge posed by BSE emerge with credit. However, there were a
       number of shortcomings in the way things were done.
   •   At the heart of the BSE story lie questions of how to handle hazard – a known
       hazard to cattle and an unknown hazard to humans. The Government took
                                                                                            xvii
FINDINGS AND CONCLUSIONS


                measures to address both hazards. They were sensible measures, but they
                were not always timely nor adequately implemented and enforced.
            •   The rigour with which policy measures were implemented for the protection
                of human health was affected by the belief of many prior to early 1996 that
                BSE was not a potential threat to human life.
            •   The Government was anxious to act in the best interests of human and
                animal health. To this end it sought and followed the advice of independent
                scientific experts – sometimes when decisions could have been reached
                more swiftly and satisfactorily within government.
            •   In dealing with BSE, it was not MAFF’s policy to lean in favour of the
                agricultural producers to the detriment of the consumer.
            •   At times officials showed a lack of rigour in considering how policy should
                be turned into practice, to the detriment of the efficacy of the measures taken.
            •   At times bureaucratic processes resulted in unacceptable delay in giving
                effect to policy.
            •   The Government introduced measures to guard against the risk that BSE
                might be a matter of life and death not merely for cattle but also for humans,
                but the possibility of a risk to humans was not communicated to the public
                or to those whose job it was to implement and enforce the precautionary
                measures.
            •   The Government did not lie to the public about BSE. It believed that the risks
                posed by BSE to humans were remote. The Government was preoccupied
                with preventing an alarmist over-reaction to BSE because it believed that the
                risk was remote. It is now clear that this campaign of reassurance was a
                mistake. When on 20 March 1996 the Government announced that BSE had
                probably been transmitted to humans, the public felt that they had been
                betrayed. Confidence in government pronouncements about risk was a
                further casualty of BSE.
            •   Cases of a new variant of CJD (vCJD) were identified by the CJD
                Surveillance Unit and the conclusion that they were probably linked to BSE
                was reached as early as was reasonably possible. The link between BSE and
                vCJD is now clearly established, though the manner of infection is not clear.



         2. The identification of the emergence of BSE

            •   Individual cattle were probably first infected by BSE in the 1970s. If some
                lived long enough to develop signs of disease, these were not reported to or
                subject to investigation by the Central Veterinary Laboratory (CVL) of the
                State Veterinary Service (SVS).
            •   The Pathology Department of the CVL first investigated the death of a cow
                that had succumbed to BSE in September 1985, but the nature of the disease
                that had caused its death was masked by other factors and was not recognised
                at the time. This is not a matter for criticism.
            •   The Pathology Department considered two further cases of BSE at the end
xviii           of 1986 and identified these as being likely to be a Transmissible
                                       EXECUTIVE SUMMARY OF THE REPORT OF THE INQUIRY


      Spongiform Encephalopathy (TSE) in cattle. This identification was
      commendable.
  •   This part of the story demonstrates both the benefits and the limitations of
      the passive surveillance system operated by the SVS.



3. The cause of BSE

  •   Gathering of data about the extent of the spread of BSE was impeded in the
      first half of 1987 by an embargo within the SVS on making information
      about the new disease public. This should not have occurred.
  •   By the end of 1987 Mr John Wilesmith, the Head of the CVL Epidemiology
      Department, had concluded that the cause of the reported cases of BSE was
      the consumption of meat and bone meal (MBM), which was made from
      animal carcasses and incorporated in cattle feed. This conclusion was
      correct. It had been reached with commendable speed.
  •   The following provisional conclusions of Mr Wilesmith, which were
      generally accepted at the time as a basis for action, were reasonable but
      fallacious:

      – the cases identified between 1986 and 1988 were index (ie, first
        generation) cases of BSE;

      – the source of infection in the MBM was tissues derived from sheep
        infected with conventional scrapie;

      – the MBM had become infectious because rendering methods which had
        previously inactivated the conventional scrapie agent had been changed.

  •   The cases of BSE identified between 1986 and 1988 were not index cases,
      nor were they the result of the transmission of scrapie. They were the
      consequences of recycling of cattle infected with BSE itself. The BSE agent
      was spread in MBM.
  •   BSE probably originated from a novel source early in the 1970s, possibly a
      cow or other animal that developed disease as a consequence of a gene
      mutation. The origin of the disease will probably never be known with
      certainty.
  •   The theory that BSE resulted from changes in rendering methods has no
      validity. Rendering methods have never been capable of completely
      inactivating TSEs.
  •   The theory that BSE is caused by the application to cattle of
      organophosphorus pesticides is not viable, although there is a possibility that
      these can increase the susceptibility of cattle to BSE.
  •   The theory that BSE is caused by an autoimmune reaction is not viable.



                                                                                        xix
FINDINGS AND CONCLUSIONS


         4. Assessment of risk posed by BSE to humans

            •   One of the most significant features of BSE and other TSEs is the fact that
                they are diseases with very long incubation periods. Thus the question
                whether BSE was transmissible to humans was unlikely to be answered with
                any certainty for many years, and scientific experiments were bound to take
                a long time. The Government had to deal with BSE against this background
                of uncertainty as to the transmissibility of the disease.
            •   MAFF officials appreciated from the outset the possibility that BSE might
                have implications for human health.
            •   By the end of 1987 MAFF officials had become concerned as to whether it
                was acceptable for cattle showing signs of BSE to be slaughtered for human
                consumption. However, the Department of Health (DH) was not asked to
                collaborate with MAFF in considering the implications that BSE had for
                human health. It should have been.
            •   Only in March 1988, by which time MAFF officials had advised their
                Minister that animals showing signs of BSE should be destroyed and
                compensation paid, did MAFF advise the Chief Medical Officer (CMO)
                Sir Donald Acheson of the emergence of BSE and ask him for his view of
                the possible human health implications.
            •   On Sir Donald’s advice, an expert working party, chaired by Sir Richard
                Southwood, was set up to advise on the implications of BSE. After their first
                meeting in June 1988, the Southwood Working Party advised that cattle
                showing signs of BSE should be slaughtered and destroyed. This advice was
                of crucial importance in safeguarding human health. The Working Party had
                concerns about some occupational health risks in relation to BSE and some
                risks posed by medicinal products. They notified the responsible authorities
                of these concerns. On 9 February 1989 they submitted a Report to the
                Government in the knowledge that it would be published. The report
                concluded that the risk of transmission of BSE to humans appeared remote
                and that ‘it was most unlikely that BSE would have any implications for
                human health’.
            •   This assessment of risk was made on the following basis:

                – BSE was probably derived from scrapie and could be expected to behave
                  like scrapie. Scrapie had not been transmitted to humans in over 200 years
                  and so BSE was not likely to transmit either.

                – So far as occupational and medicinal risks were concerned, the authorities
                  which had been notified about these could be relied upon to take
                  appropriate measures to address them.

            •   The Report did not, as it should have done, make clear the basis for its
                assessment of risk. It did comment that if the assessment was incorrect the
                implications would be extremely serious. This warning was lost from sight.
                The Southwood Report was, in years to come, repeatedly cited as
                constituting a scientific appraisal that the risks posed by BSE to humans
                were remote and that no precautionary measures were needed other than
xx              those recommended by the Working Party.
                                      EXECUTIVE SUMMARY OF THE REPORT OF THE INQUIRY


  •   Precautionary measures were nonetheless put in place that went beyond
      those recommended by the Working Party. The wisdom of those measures
      was demonstrated as the years went by and facts were learned about BSE
      which threw doubt on the theory both that it was derived from scrapie and
      that it would behave like scrapie.
  •   In May 1990 a domestic cat was diagnosed as suffering from a ‘scrapie-like’
      spongiform encephalopathy. This generated widespread public and media
      concern that BSE had been transmitted to the cat and might also be
      transmissible to humans. Subsequently, more domestic cats were similarly
      diagnosed. These events shifted the perception of some scientists of the
      likelihood that BSE might be transmissible to humans. By 1994 the
      Spongiform Encephalopathy Advisory Committee (SEAC) evaluated the
      risk of transmissibility to humans as remote only because precautionary
      measures had been put in place.



5. Communication of the risk posed by BSE to humans

  •   The increasing knowledge about BSE over the years, which threw doubt on
      the theory that it would behave like scrapie, was not concealed from the
      public. However, the public was not informed of any change in the perceived
      likelihood that BSE might be transmissible to humans.
  •   The public was repeatedly reassured that it was safe to eat beef. Some
      statements failed to explain that the views expressed were subject to proper
      observance of the precautionary measures which had been introduced to
      protect human health against the possibility that BSE might be transmissible.
      These statements conveyed the message not merely that beef was safe but
      that BSE was not transmissible.
  •   The impression thus given to the public that BSE was not transmissible to
      humans was a significant factor leading to the public feeling of betrayal
      when it was announced on 20 March 1996 that BSE was likely to have been
      transmitted to people.



6. Measures to eradicate the disease in cattle

  •   Once Mr Wilesmith had identified MBM as the probable vector of BSE, the
      Government introduced the appropriate measure to prevent further infection
      and to stop the spread of the BSE agent – a ban on incorporating ruminant
      protein in ruminant feed. This had a dramatic effect in reducing to a fraction
      what had been an escalating rate of infection. It did not, however, bring
      infection to an end.
  •   The manner in which the Government introduced the ruminant feed ban was
      influenced by misconceptions as to:

      – the scale of the infection;

      – the amount of infective material needed to transmit the disease.               xxi
FINDINGS AND CONCLUSIONS


            •   Ignorant of the fact that the rate of infection had escalated to thousands of
                cases a week, the Government gave the animal feed trade a ‘period of grace’
                of some five weeks to clear existing stocks of feed before the ban took effect.
                Some members of the feed trade, being given an inch, felt free to take a yard
                and continued to clear stocks after the ban came into force. Farmers in their
                turn used up the stocks that they had purchased. This led to thousands of
                animals being infected after the ruminant feed ban came into force on 18 July
                1988.
            •   More serious was a failure to give rigorous consideration to the amount of
                infective material that was proving capable of transmitting the disease. The
                false assumption was made that any cross-contamination of cattle feed in
                feedmills from pig or poultry feed containing ruminant protein would be on
                too small a scale to matter.
            •   In fact, as subsequent experiments were to demonstrate, a cow can become
                infected with BSE as a result of eating an amount of infectious tissue as small
                as a peppercorn. Cross-contamination in feedmills resulted in the continued
                infection of thousands of cattle. Because it takes, on average, five years after
                initial infection for the clinical signs of BSE to become apparent, this was
                not appreciated until 1994.
            •   From September 1990 contamination of cattle feed with pig and poultry feed
                should not have resulted in infection. This was because, following the
                experimental transmission of BSE to a pig, MAFF on the advice of SEAC
                introduced a measure in September 1990 aimed at protecting pigs and
                poultry from BSE. This was a ban on the inclusion in pig and poultry feed of
                MBM derived from the parts of the cow that might be expected to carry high
                infectivity if an animal were incubating or suffering from the disease –
                ‘Specified Bovine Offal’ or SBO.
            •   However, there was a failure to give proper thought to the terms of this
                measure when it was introduced. The animal SBO ban was unenforceable
                and widely disregarded. Infectious bovine offal continued to find its way into
                pig and poultry feed and then, by cross-contamination, into cattle feed.
            •   Only in 1994 did the fact of the continuing infection and the reasons for it
                become appreciated. Regulations were revised and a rigorous enforcement
                campaign launched to coincide with the takeover in 1995 by a new national
                Meat Hygiene Service (MHS) of the enforcement duties in slaughterhouses,
                previously carried out by local authorities. The success of these measures is
                now becoming apparent. They were replaced after 20 March 1996 by the
                radical step of banning the incorporation of all animal protein in animal feed.



         7. Measures to address the risks posed by BSE to
         humans

         Slaughter and compensation

            •   Compulsory slaughter and destruction of all animals showing signs of BSE
                was a crucial measure to protect human health and, incidentally, animal
xxii
                                       EXECUTIVE SUMMARY OF THE REPORT OF THE INQUIRY


      health. It prevented the use, for any purposes, of sick animals, which could
      otherwise have been sent to the slaughterhouse for human consumption.
  •   A compulsory slaughter and compensation scheme was introduced in
      August 1988, following the commendable interim advice of the Southwood
      Working Party. Had there been prompt and adequate collaboration between
      MAFF and DH, this measure could and should have been introduced months
      earlier.
  •   Levels of compensation to farmers were adjusted on two occasions, but at no
      time did they lead to any significant failure to comply with the duty to notify
      the SVS of animals showing signs of BSE.

Food risks

  •   The Southwood Working Party considered that all reasonably practicable
      precautions should be taken to reduce the risks that would exist should BSE
      prove to be transmissible to humans. However, they did not make this plain
      in their Report and did not recommend that the possible risks from eating
      animals incubating BSE but not yet showing signs of the disease
      (‘subclinical cases’) called for any precautions, other than a
      recommendation that manufacturers should not include ruminant offal and
      thymus in baby food. This was a shortcoming in their Report.
  •   Because of a failure to subject the Southwood Report to an adequate review,
      MAFF and DH failed to identify this shortcoming. Concern about the food
      risks posed by subclinical cases was, however, expressed by some scientists,
      by the media and by the public. With the agreement of DH, MAFF reacted
      by announcing in June 1989 that those categories of offal of cattle most
      likely to be infectious (SBO) were to be banned from use in human food. The
      introduction of this vital precautionary measure was commendable.
      However, this ban was presented to the public in terms that underplayed its
      importance as a public health measure.
  •   Careful consideration was given by MAFF and DH in 1989 to the terms of
      the human SBO ban, with one important exception. During the consultation
      process, concerns were raised about the practicality of ensuring the removal
      of all of the spinal cord during abattoir processes, and about the practice of
      mechanical recovery of scraps left attached to the vertebral column for use
      in human food (‘mechanically recovered meat’ or MRM). However, MAFF
      officials discounted these concerns without subjecting them to rigorous
      consideration – in particular no advice was sought as to the minimum
      quantity of spinal cord that might transmit the disease in food.
  •   MAFF gave detailed consideration to spinal cord and MRM in 1990. A
      lengthy paper was submitted to SEAC, the Government’s new expert
      advisory committee on TSEs. Unhappily, as a result of a breakdown of
      communications, MAFF officials understood that the members of SEAC
      were not concerned about the inclusion in human food of an occasional scrap
      of spinal cord, so that no action was called for. In fact the advice of some, at
      least, of the members of SEAC was premised on the false assumption that
      spinal cord could readily be removed from the carcass in its entirety, and
      would be so removed.
                                                                                         xxiii
FINDINGS AND CONCLUSIONS


            •   This was one of a number of occasions that has given rise to lessons for the
                future about the proper use of expert committees by the Government.
            •   Not until 1995 was action taken in relation to MRM. Following the takeover
                by the Meat Hygiene Service of the enforcement of Regulations in
                slaughterhouses, occasional instances were discovered of failure to remove
                all spinal cord from the carcass. Strenuous and successful steps were taken
                to improve standards of compliance with the Regulations in slaughterhouses.
                Eventually, in December 1995, on SEAC’s advice the extraction of MRM
                from the spinal column of cattle was banned.
            •   Up to 1995, MRM was a potential pathway to the infection of humans with
                BSE, not merely because of the risk of inclusion of the occasional portion of
                spinal cord, but because the material recovered by the MRM process
                included dorsal root ganglia. These were peripheral nervous tissues which
                were not thought to be infectious at the time, but which have since been
                demonstrated to be infectious in the late stages of incubation.



         8. Medicines

            •   Despite the highly regulated licensing regime for medicines, systematic
                records of the action taken in response to BSE in respect of individual
                medical products are lacking.
            •   Past experience of the transmission of animal disease through vaccines, and
                of transmission of CJD through medication and through the contamination
                of surgical instruments, showed that minute particles of infected tissue from
                an apparently healthy donor could transmit a TSE.
            •   MAFF officials recognised in 1987 that there was a risk that BSE might be
                transmitted through veterinary products and began to take steps to address
                this risk which were commendable. They failed, however, to share their
                concerns with those in DH who were responsible for handling human
                medicinal products. This was inadequate interdepartmental liaison.
            •   On learning of BSE in March 1988 the CMO, Sir Donald Acheson, sought
                to ensure that the potential risks that the disease posed in relation to human
                medicinal products were addressed. However, Medicines Division (MD) did
                not bring the matter before their advisory committees until November 1988.
                Of this period, two months’ delay was attributable to a failure to accord the
                matter appropriate priority.
            •   MD did not appreciate the extent of the concern felt by the Southwood
                Working Party about medicines administered by injection and about the
                existing stocks of these. This was compounded by the wording of the
                Southwood Report, which described the risk posed by medicines as remote
                without making it plain that this risk assessment was predicated on the
                assumption that remedial measures were being taken to address the risk.
            •   Having regard to the legislative constraints, it was reasonable to issue
                guidelines in relation to both human and veterinary medicinal products
                rather than resort to direct regulatory action.

xxiv
                                    EXECUTIVE SUMMARY OF THE REPORT OF THE INQUIRY


•   Production of the relevant human and veterinary medicines involved similar
    raw materials and processes. The approach in respect of each needed to be
    consistent. Yet DH and MAFF did not discuss joint guidelines until January
    1989. Once again this reflected inadequate interdepartmental liaison.
•   The decision to continue to use existing vaccine stocks until these could be
    replaced was reasonable. Vaccines cannot be produced overnight. An
    embargo on existing stocks would have led to interruptions, potentially
    lengthy, in vaccination programmes. The overwhelming professional
    opinion at the time was that there was bound to be death and disablement in
    the event of breaks in the vaccination programmes, on a scale which far
    outweighed the potential risks from BSE. Some comfort can be derived from
    the 1993 results of tests carried out on bovine serum by the
    Neuropathogenesis Unit (NPU), which failed to lead to infection in mice.
•   The task of identifying medicinal products to which the guidelines applied
    was made more difficult and protracted by:

    – the inadequate database of licensed products;

    – the need to make case-by-case enquiries in relation to thousands of
      products;

    – inadequate staffing;

    – unclear management responsibilities; and

    – the administrative dislocation involved in reorganisation at the time of the
      relevant DH and MAFF divisions as Executive Agencies.

    Staff from the two new Agencies – the Medicines Control Agency (MCA)
    and the Veterinary Medicines Directorate (VMD) – worked diligently to
    overcome these difficulties.

•   The establishment of the BSE Working Group with a high-powered
    membership to advise all of the section 4 committees on human medicinal
    products thought to pose a potential risk was a sound decision.
•   The small number of products that included high-risk tissues as an ingredient
    was identified and dealt with reasonably promptly.
•   The role of the BSE Working Group, like that of the Committee on Safety of
    Medicines (CSM) and Veterinary Products Committee (VPC), was purely
    advisory. The task of identifying individual products for consideration by the
    Group and following up recommendations made by the Group was for
    officials.
•   Decisions taken in relation to individual medicinal products were
    reasonable, but the speed with which decisions were taken and followed up
    suffered from lack of clear and purposeful leadership in the MCA.
•   More effective handling arrangements were adopted within DH’s
    Procurement Division (serving the National Health Service) to review
    medical devices.
                                                                                     xxv
FINDINGS AND CONCLUSIONS


            •   Existing stocks of a small number of human vaccines prepared using bovine
                tissues may have been used up to 1992 and of animal vaccines for even
                longer.
            •   The decision to continue using existing stocks of vaccines was not
                considered to be one that needed to be taken or approved by Ministers. Had
                it been, we consider that Ministers would have accepted the overwhelming
                professional advice, but would have been concerned to see that the process
                of phasing out these stocks was more vigorously pursued.
            •   Officials in the MCA and VMD do not appear to have been systematically
                accountable to anyone for the manner in which the phasing out exercise was
                handled. Nor, given the low-profile handling, was there any parliamentary
                or public scrutiny of their actions.



         9. Cosmetics

            •   Cosmetics, like topically applied medicines, might be applied to the skin,
                eye or mucous membranes but were covered by a less stringent regulatory
                regime under the aegis of the Department of Trade and Industry (DTI). The
                category presenting the highest risk comprised ‘exotica’ or ‘premium
                products’, such as anti-ageing creams, which might contain lightly processed
                brain extracts, placental material, spleen and thymus.
            •   MAFF and DH failed to alert DTI to the need to consider the risk through
                cosmetics from BSE despite this having been identified by the Tyrrell Report
                in June 1989. This contributed to several months’ delay in the start of action
                to secure their safety.
            •   Guidance was provided to the industry in February 1990 on the initiative of
                DTI, but was made available only to members of the cosmetics and toiletries
                trade association. This was the most significant single action to address the
                risk from cosmetics.
            •   Thereafter no further initiative was taken by DTI. A muddled situation
                developed about lead responsibility for action. Responsibility for taking
                action should have been clearly understood to rest with DTI with
                professional advice from DH.
            •   Following a request from SEAC in July 1991 for the cosmetics guidance to
                be updated, DH omitted to advise DTI about this and subsequently made its
                own unsuccessful approach to the trade association in April 1992 seeking
                detailed information. DTI was brought back into the picture only in
                September 1992 at a meeting between DH, MAFF and the trade association.
            •   The confusion about lead responsibility both between Departments and
                within DH continued thereafter, and responsibility for updated UK guidance
                was effectively left with the trade association. The topic became embroiled
                in protracted negotiations at European level on EU guidelines, and the trade
                association UK guidance did not emerge until 1994.
            •   The hallmarks of the handling of BSE in relation to cosmetics were lack of
                purposeful leadership and an absence of a sense of urgency. Manufacturers
xxvi            were left to use up stocks, and checks were not made to ensure they
                                      EXECUTIVE SUMMARY OF THE REPORT OF THE INQUIRY


      reformulated their products. This has left unanswered questions both about
      what material was being used, and about how long production continued and
      on what scale.



10. Occupational risk

  •   The possibility of contracting illness from contact with diseased animals or
      their tissues was a well-recognised occupational hazard. Workers in a wide
      range of occupations were potentially in contact with the tissues of BSE-
      infected cattle or with those of human victims. All of these occupations
      needed to be identified and to receive appropriate guidance about the
      precautions to reduce risk in respect of BSE and other TSEs.
  •   The delays in issuing advice to many of those concerned were unacceptable.
      Ultimately the main occupations at risk were identified and advice given.
      But a detailed chronology shows that it took over three years to complete the
      task of issuing simple warnings and basic advice to the most obvious high-
      risk trades.
  •   Work began in 1991 on guidance to those handling risk tissues in
      laboratories, hospitals and mortuaries. This took until September 1994 to
      be completed and issued. During that process a so-called ‘fast track’
      professional letter took 14 months to prepare.
  •   In a different field, it took two-and-a-half years for advice to be issued to
      schools about risks from dissecting bovine eyeballs, though SEAC had asked
      in June 1990 for this to be done.
  •   The slow and erratic responses have indicated weaknesses in the standard
      system for handling a wide-ranging disease threat. The slow tempo of action,
      in part attributable to time spent on polishing and refining advice, stemmed
      from three factors:

      – a failure in communication: the perception that the Southwood Report had
        indicated that the risk to humans from BSE was remote even without any
        further action, and a belief in the Health and Safety Executive (HSE) that
        action was being taken simply as a response to political and media
        pressures;

      – the absence of a comprehensive review of pathways of transmission, which
        might have helped pinpoint where the issue of urgent advice could not
        wait;

      – the decision to use the slow-paced existing consultative and drafting
        arrangements. This ought not to have been at the expense of prompt and
        straightforward interim warnings.

  •   The mistakes made in handling the occupational threats from BSE and the
      questions raised by them need to be carefully considered by the HSE.


                                                                                      xxvii
FINDINGS AND CONCLUSIONS


         11. Other pathways of infection

            •   There was a need to establish all the pathways by which bovine products or
                by-products might come into contact with humans or other animals. This
                need was recognised by MAFF officials at an early stage and also by the
                Government’s expert advisers on BSE. However, the exercise was never
                carried out prior to March 1996. As a result, no coordinated or
                comprehensive consideration was given to the various routes by which BSE
                might infect human beings or other animals.



         12. Pollution and waste control

            •   MAFF was directly responsible for disposing of cattle carcasses from the
                compulsory slaughter scheme. Major problems included the large volume of
                carcasses and initial serious underestimation of the numbers that would
                arise. MAFF handled this difficult and unpopular disposal task energetically
                and competently.
            •   The disposal of SBO material was not MAFF’s direct responsibility and was
                less straightforward to manage. Initially this material did not constitute
                waste as such because it was a marketable product for rendering into tallow
                and MBM. It did not become controlled waste, to be disposed of only at a
                licensed destination, until after the animal SBO ban and SEAC advice that
                the protein product of SBO should not be used as an agricultural fertiliser.
            •    Other forms of waste included effluent passing down drains to sewers and
                rivers. None of the usual precautions or conditions attached by water
                authorities to discharges would have inactivated the BSE agent.
            •   Blood, slaughterhouse and rendering plant waste, including that from plants
                that rendered SBO, and sewage sludge from works handling their effluents,
                might lawfully be spread as agricultural fertiliser.
            •   Some of the failures to identify and address these matters promptly can be
                attributed to the defective state of environmental regulatory action at the
                time, and the transitional turmoil of measures to rectify this.
            •   General waste disposal systems as a potential transmission pathway for BSE
                received scant attention from those handling BSE prior to 1996. The matter
                was not referred to or addressed by the Southwood Working Party, the
                Tyrrell Committee or SEAC. All of them advocated a systematic review of
                the destination of all bovine materials. Had this been carried out, it might
                have identified waste disposal issues.



         13. The identification of vCJD

            •   The Southwood Working Party noted that if BSE were to be transmitted to
                humans it would be likely to resemble CJD and suggested that surveillance
                be put in place to identify atypical cases or changing patterns of the disease.
xxviii
                                     EXECUTIVE SUMMARY OF THE REPORT OF THE INQUIRY


  •   The task of detecting any variation in the characteristics of cases of CJD
      which might indicate infection with BSE was entrusted to the CJD
      Surveillance Unit (CJDSU), a research team of dedicated medical scientists
      headed by Dr Robert Will, a neurologist with extensive experience of CJD.
  •   No role in this was given to the Public Health Laboratory Service (PHLS),
      an established service for the surveillance of new and existing disease,
      among other things.
  •   The decision to establish a new team specifically for this purpose was
      vindicated by the prompt detection of the emergence of vCJD by the CJDSU.
  •   The conclusion reached by SEAC on 16 March 1996 that the most likely
      explanation for the cases of a new variant of CJD in young people was
      exposure to BSE has since been compellingly supported by scientific
      evidence.
  •   It should have been apparent to both MAFF and DH by early February 1996
      at the latest that there was a serious possibility that the scientists would
      conclude that it was likely that BSE had been transmitted to humans. The
      two Departments should have worked together, in consultation with SEAC,
      to explore the possible policy options that would be available should this
      occur.
  •   There was no interdepartmental discussion or consideration of policy
      options within either Department until the middle of March 1996. The views
      of SEAC were awaited, both as to whether the cases of vCJD were linked
      with BSE, and as to what action should be taken if they were. This was an
      inadequate response.
  •   Under intense pressure from the Government, on 20 March 1996 SEAC
      advised among other things that the appropriate course was that carcasses
      from cattle over 30 months old should be deboned in licensed plants
      supervised by the Meat Hygiene Service and the trimmings classified as
      SBO.
  •   The Government immediately announced that it was accepting this advice.
      In doing so it was wrong-footed, for this course proved neither practicable
      nor acceptable to the public. A policy of banning consumption of cattle over
      30 months had to be introduced instead.



14. Victims and their families

  •   The unusual problems of the diagnosis, treatment and care of the early cases
      of vCJD meant that for some of the victims and their families the tragic
      horror of the disease was made the more difficult to bear by lack of the
      appropriate treatment, assistance and support.
  •   Victims of vCJD and their families have special needs which should be
      addressed.



                                                                                     xxix
FINDINGS AND CONCLUSIONS


         15. Research

            •   The Southwood Working Party made wise recommendations in relation to
                research, not least that an expert committee be set up to advise on this.
            •   That committee, the Tyrrell Committee, rapidly recommended research
                priorities which formed the basis of much of the research that followed.
            •   After some initial delay, BSE research was adequately funded by the
                Government.
            •   Attempts to agree that a director, or ‘supremo’, should oversee and
                coordinate research were initiated by Sir Donald Acheson but foundered in
                the face of concerns on the part of the Research Councils and MAFF for their
                independence.
            •   Coordination of research effort is desirable in order to achieve:

                – identification of gaps in research;

                – determination of research priorities;

                – identification of the best sources of expert assistance;

                – a well-constructed plan for funding from the outset;

                – competition for research projects;

                – peer review of projects; and

                – efficient arrangements for provision of clinical material to researchers.

            •   A research supremo might have identified the following areas where
                research could profitably have been started earlier or pursued with more
                vigour:

                – experiments to transmit scrapie to cattle to test the scrapie origin
                  assumption;

                – tests for BSE in sheep;

                – identification of the minimum infective dose which could transmit BSE
                  orally to cattle;

                – assessment of the sensitivity of mice to BSE for use in experiments;

                – ante- and post-mortem tests for BSE;

                – a test for ruminant protein in compound feed;

                – epidemiology.


xxx
                                      EXECUTIVE SUMMARY OF THE REPORT OF THE INQUIRY


16. Some general lessons

  •   The lessons to be learned from the BSE story are set out in Chapter 14 of this
      volume.




                                                                                       xxxi
FINDINGS AND CONCLUSIONS




xxxii
1. Introduction
1 In December 1986 a new animal disease was discovered by the State Veterinary
Service. It quickly became known as Bovine Spongiform Encephalopathy or BSE.
It caused irreversible ‘spongy’ changes to the brains of cattle and was invariably
fatal. The public called it ‘mad cow disease’.

2 For ten years the Government told the people:

    •     there is no evidence that BSE can be transmitted to humans;
    •     it is most unlikely that BSE poses any risk to humans; and
    •     it is safe to eat beef.

3 Then, on 20 March 1996, Mr Stephen Dorrell, the Secretary of State for Health,
stood up in Parliament and announced that ten young people had contracted a new
variant of the harrowing, and invariably fatal, Creutzfeldt-Jakob disease – vCJD –
and that it was probable that they had caught BSE. Further cases of vCJD were to
follow. By September 2000 there had been over 801 cases and the frequency with
which they were being reported seemed to be growing.

4 For nearly three years we have been examining all that is known about the history
of BSE and vCJD and looking at how these diseases were handled by the
Government and by others in the period between December 1986 and 20 March
1996. This Report sets out what we have found.

5 In 1986 the United Kingdom had a worldwide reputation for competence and
efficiency in animal health and welfare matters, and in the handling of outbreaks of
serious animal diseases. Its skilled veterinarians and scientists, with the State
Veterinary Service and veterinary laboratories in the forefront, operated established
processes to identify, contain and eradicate animal diseases. They worked closely
with farmers, veterinarians in private practice, public health professionals and the
relevant industrial sectors. They raised awareness, gave advice, and recommended
statutory regulation where appropriate and compensation if need be. The process
required well-established communication between advisers and practitioners,
effective systems of animal surveillance and information-gathering, programmes of
research, and detailed shared understanding of the links between animal and human
health in all its aspects, including the food chain.

6 The UK also had highly regarded public health processes of long standing to
handle outbreaks of human disease. These included surveillance, preventive action,
such as immunisation and advice, and treatment. The health of the nation was at the
heart of the remit of the Health Ministers and the professional responsibility of
the four Chief Medical Officers, one for each part of the UK, who advised
the Government.

7 What went wrong after the new fatal degenerative brain disease of cattle, BSE,
emerged in 1986? Why did the announcement in 1996 that humans had probably

1
    Including probable cases who were still alive                                       1
FINDINGS AND CONCLUSIONS


         been struck down by this particular brain disease find the guardians of public health
         and the world at large so shocked, and apparently unprepared, and leave the public
         so disillusioned? Our remit does not extend to the frantic diplomatic activity and
         other events after that date, but the consequences are still bearing heavily on the
         British economy and have inflicted tragedy on some families and left blighting
         uncertainty and fear hanging over many more.

         8 The full extent and effects of the human disease will not be discernible for many
         years to come. Baffling questions include the unusual nature of Transmissible
         Spongiform Encephalopathies (TSEs), the reasons why specific people have
         become prey to the human version of BSE, and the extent to which others,
         particularly those exposed to the agent in the 1980s, may yet develop it. These
         difficult and still unresolved questions have hampered and bedevilled the whole
         course of events. What we do know is that as of September 2000, shortly before
         publication of this Report, over 80 victims of vCJD, most of them young, had had
         their lives destroyed and their families’ happiness and hopes had been irreparably
         damaged.

         9 BSE has been a peculiarly British disaster. Almost all the victims of vCJD have
         been in the United Kingdom. Only four other human victims of vCJD have been
         diagnosed elsewhere.2 Over 170,000 cattle have been diagnosed with BSE here
         compared with fewer than 1,500 abroad, mostly it would appear traceable to British-
         sourced animals or infected feed at the beginning of the British epidemic. So far,
         over 4.7 million British cattle have had to be slaughtered, and their carcasses
         burned or buried as potentially dangerous waste.3 A thriving high-quality cattle and
         meat export industry has been wiped out. The livelihood of thousands of farmers
         and businesses has been damaged. Even at this tail-end of the animal epidemic there
         were still over 2,000 cases of BSE notified in 1999 and cases continue to be
         reported as we write.

         10 Small wonder that people want to know why it happened and whether it was
         handled wisely and well. In particular:

             •     What was the cause of BSE emerging and spreading country-wide? Was it
                   as a result of intensive modern farming practices? Was it a result of
                   inadequate regulation or lowered standards? Why is it so overwhelmingly
                   the UK that has been afflicted?
             •     Seventy-four victims, mostly young people, have died of a new variant of
                   CJD. Is it certain that they contracted this dreadful disease as a result of some
                   form of connection with BSE? If so, why was it that they were struck down?
             •     Was the emergence of BSE and its threat to human health effectively
                   handled by those whose responsibility it was to do so?
             •     Did individuals respond as they should have done, having regard to the state
                   of knowledge at the time?
             •     Was the truth about the nature of BSE and the threat it posed concealed from
                   the public? Has there been a cover-up?
             •     Did we make proper use of our scientists?
         2
             This represents two confirmed and one probable case in France and one confirmed case in the Republic of Ireland.
             Source: CJD Surveillance Unit, 20 September 2000
2        3
             Figures up to 30 June 2000. Source: MAFF
                                                                                 INTRODUCTION


   •   Did our health and welfare services adequately cater for the special needs of
       those who contracted vCJD and their families?
   •   What lessons does the catastrophic course of events hold for public policy
       and the way we do things in the future?

11 These questions have been very much in our minds throughout this Inquiry, as
we have explored exactly what happened day by day during the ten years that led
up to the announcement of 20 March 1996 that BSE had probably generated a new
and fatal human disease. Some questions, such as the numbers who are likely to
succumb to the human disease, we are not in a position to answer. Our remit is to
report to Ministers on the course of events and the adequacy of the responses to
them in the light of knowledge at the time. We have sought to do so thoroughly and
fairly. We have reviewed not only the years since BSE first emerged, but the events
that led up to it. We have read a large number of scientific publications. We have
sifted 3,000 files of documents, and have studied 1,200 statements and many
contributions from the public, whom we have sought to keep fully up to date with
every stage of our proceedings. We have listened to 138 days of public oral evidence
from 333 witnesses.

12 A recurring theme in the BSE story – a point we look at in detail later in our
Report – has been growing public suspicion and dissatisfaction that important
information was not being shared and discussed openly so that people were denied
proper choices in matters that deeply affected them and their families. One of our
goals in settling the conduct of our Inquiry was to make our investigations as open
as good practice and modern technology could ensure, with any significant material
we received made freely available to all. Witnesses’ statements and transcripts of
our hearings have been made available free of charge to all with access to the
Internet. Hundreds of fuller dossiers of assembled factual material have throughout
been available in more conventional form for those who wish to inspect them at our
offices. We have placed in the public domain a unique corpus of official documents,
and we have sought to throw light on a range of normally internal public policy
processes. Our aim has been to be as thorough, open and fair as we could possibly
be. Annex 1 to this volume describes the procedures we adopted for this purpose.

13 We have welcomed the spirit of cooperation we have been shown by the
previous and current administrations and many other organisations in opening their
archives to us. As some of our witnesses pointed out, they too are consumers of
animal products and they too have children and grandchildren whom they cherish.
We have made heavy demands for information on many witnesses and the voluntary
response has been remarkable.



Our task

14 Our Terms of Reference require us:

       To establish and review the history of the emergence and identification of
       BSE and variant CJD in the United Kingdom, and of the action taken in
       response to it up to 20 March 1996; to reach conclusions on the adequacy of
       that response, taking into account the state of knowledge at the time; and to
                                                                                        3
FINDINGS AND CONCLUSIONS


                report on these matters to the Minister of Agriculture, Fisheries and Food,
                the Secretary of State for Health and the Secretaries of State for Scotland,
                Wales and Northern Ireland.

         15 Establishing and reviewing the history of the emergence of BSE and vCJD
         requires us to consider what occurred and why. Ascertaining what occurred is not
         straightforward, for we believe that the initial emergence of BSE was neither
         recorded nor appreciated, and the aid of the epidemiologist is needed to try to
         reconstruct what happened. Ascertaining why BSE and vCJD occurred is even more
         difficult. Many scientists around the world have been conducting research which
         bears on these questions. We have reviewed the results of this research to see what,
         at the time of writing our Report, can be said with a reasonable degree of confidence
         about the causes of BSE and vCJD. Many questions remain unanswered, but we
         believe that a number of widely held beliefs can be shown to be misconceptions.

         16 Next we are required to establish and review the history of the response to the
         emergence of BSE and vCJD up to 20 March 1996. That was the day on which the
         Government announced the identification of a new variant of CJD and the
         conclusion that the cases were probably linked to exposure to BSE.

         17 Establishing the response to the emergence of vCJD involves focusing on the
         few months leading up to 20 March 1996, during which the emergence of the
         disease was identified. In contrast, considering the action taken in response to the
         emergence of BSE has been a massive exercise. That action spanned a period of
         nearly ten years, starting in December 1986, when the emergence of a new disease
         in cattle was first suspected. The action involved the five Government Departments
         to which this Report is addressed, and on occasion other Departments, the Prime
         Minister and Cabinet. It involved local authorities throughout the United Kingdom
         charged with enforcing Regulations introduced to deal with BSE. It involved many
         other public bodies. It involved the rendering industry, the animal feed industry, the
         food industry, the pharmaceutical industry, and, of course, the farming industry.
         It involved the media. It involved the consumer and it involved the public.

         18 When we speak of the consumer, we do not refer simply to those who ate beef.
         Products derived from the cow enter the food chain in a variety of guises. Tallow,
         the fat that is extracted by the rendering process, and gelatine, derived from the skin
         and bones of cattle, are used in a wide variety of foodstuffs. But the public was
         involved not merely as consumers of food. Bovine tissues and fluids are used in, or
         in the production of, medicinal products swallowed, injected or inoculated. They are
         used in the manufacture of surgical devices. They are incorporated in cosmetics.
         The emergence of BSE put in question the safety of each of these products. It also
         raised questions about the handling of waste derived from the manufacture of these
         products or directly from carcasses.

         19 Not only have we been required to establish the action taken in response to the
         emergence of BSE, we have been asked to reach conclusions on the adequacy of the
         response, taking into account the state of knowledge at the time.




4
                                                                                   INTRODUCTION


20 On the last day of the hearings we made the following observations about this
part of our task:

       The mechanisms by which policy decisions in Government are taken are
       complex. The important decisions involve preparation of information and
       advice to submit to a Minister, preparation that often involves a number of
       different officials. It is easy with hindsight to assert that an assumption
       should not have been made, or that a decision was inadequate, misguided or
       dilatory, or that there was a culpable failure to take action that the situation
       required. Public opinion, as events unfolded and reached crisis point, has
       made many such value judgements. Hardly a day goes by today without BSE
       being referred to in the media as epitomising maladministration, usually by
       the use of an epithet such as ‘the BSE scandal’. We believe that we have been
       asked to consider the adequacy of the response to BSE so that these
       accusations, insofar as they relate to the period with which we are concerned,
       can receive a fair and dispassionate consideration.

21 As we shall shortly explain, in the years with which we are concerned, most of
those responsible for responding to the challenge posed by BSE emerge with credit.
But we have found that a number of aspects of the response to BSE were inadequate.
There are lessons to be learned from the events of those years. We stress that
identifying those lessons is more important than examining whether individuals
should be criticised. Nevertheless, any description of inadequacies is bound to lead
people to ask whether individuals are to be criticised. We have given anxious
consideration to that question.

22 A finding that an action constituted an inadequate response to BSE does not
necessarily mean that those responsible for the action should be criticised. An action
may not have been adequate because it did not satisfactorily deal with things that
were known about a problem at the time. But it would not be right to criticise an
individual unless, given the knowledge of that particular individual, he or she
should have acted differently.

23 We have approached our task on the premise that it ought to be possible to
identify those with responsibility for the policy decisions, the actions to implement
policy and the public communications that together made up the response to BSE.

24 In practice we have found allocation of individual responsibility difficult.
In part this has been due to the passage of time, which has rendered individual
recollection of material facts at least unreliable and frequently non-existent. In part
this has been due to the complexity of the administrative processes. The willingness
of those concerned to give us unrestricted access to internal papers, and to disclose
these to the public, has enabled us and the media and the public to gain an insight
into those processes which we believe to be unprecedented.

25 Our Inquiry has led us to consider in depth:

   •   the relationship between Ministers and officials;
   •   the relationship between Government Departments;
   •   the relationship between administrators and professionals within
       Departments;                                                                       5
FINDINGS AND CONCLUSIONS


            •   the relationship between public authorities and expert advisers; and
            •   the relationship between central and local government.

         26 These relationships formed the structure within which major and minor
         decisions of policy came to be taken and implemented.

         27 When considering individual responsibility we have had to bear in mind this
         structure. We have had to bear in mind the way in which the public administrative
         system works. Many decisions are the product of a team effort to which individuals
         have made different contributions. A faulty decision may be the result of an error of
         judgement in assessing the available scientific and other data, or it may have
         resulted from an individual failure or failures in the provision of data, or the
         provision of expert advice in relation to it.

         28 We have had to bear in mind the constraints on advisers and decision-makers:
         constraints of law, constraints of resources, constraints of established government
         policy; and constraints of the legitimate interests of the agricultural and other
         industries as well as those of the consumer. The background volumes of our Report
         (which, as we explain below, have been prepared by Inquiry staff) contain
         information about these constraints.

         29 We describe in Annex 1 to this volume the procedures that we adopted to ensure
         that this Inquiry was thorough, open and fair. These included particular procedures
         adopted in Phase 2 of the Inquiry for those areas which we considered might give
         rise to criticisms of individuals. Fairness demanded that individuals be given notice
         of any potential criticisms. Such a course had its costs. Those notified of potential
         criticisms, and the lawyers advising them, naturally devoted and diverted their
         efforts to attempting to meet the criticisms. This tended to focus attention on the
         areas to which the potential criticisms related, albeit that these were not necessarily
         the most important areas of the Inquiry, and thus to unbalance the process.

         30 In considering the adequacy of the action of individuals we have kept in the
         forefront of our minds the dangers of hindsight. We have had regard to all the
         surrounding circumstances which have often explained and excused action which at
         first blush seemed open to criticism. We have had well in mind that in any situation
         there is likely to be a range of responses from the inspired to the unimaginative, all
         of which fall within the compass of a reasonable response. Only where, having
         regard to all the relevant circumstances, we have concluded that the response of an
         individual fell below the standard to be expected of a person holding his or her
         position, have we indicated that the individual was at fault. We have done so in clear
         language, stating that the individual ‘should’ or ‘should not’ have acted in a
         particular way. Where we have not made an express criticism, none should be
         implied. So as to avoid any misunderstanding, a list of individual criticisms can be
         found in Annex 2 to this volume, with cross-references to locations in the Report
         where the matter is discussed.

         31 Consistently with this approach, when considering the actions of Government
         Ministers, we have not adopted the traditional convention whereby Ministers are
         held accountable for the actions of those in their Department, regardless of their
         personal level of involvement. As with other individuals, we have only criticised a
         Minister where we have concluded that, in all the circumstances, his or her response
6
                                                                                     INTRODUCTION


fell below the standard to be expected of that Minister in the light of his or her
knowledge at the time.

32 This is not to say that we have proceeded on the basis that a Minister should
never be criticised for following advice from officials. The fact that a Minister has
followed this course cannot preclude the conclusion that he or she should have acted
differently. It is, however, an important factor when considering whether a Minister
should be criticised.

33 There are some instances where we have found the response inadequate, but
have not identified failings on the part of specific individuals. These are usually
cases where we have felt that, having regard to the constraints on our time and
resources, an attempt to identify individual responsibility could not be justified.
In all such instances we would emphasise that it would be wrong and unfair to infer
fault on the part of any individual.



The structure of the Report

34 Almost every aspect of the BSE story takes us into territory that may well be
unfamiliar to the average reader of this Report. Anyone who wishes to follow the
story fully will need to understand:

   •   the involvement of government in UK agriculture during and after the
       Second World War;
   •   the influence of the Common Agricultural Policy on agricultural production;
   •   the digestive system of the cow;
   •   intensive feeding methods designed to boost milk production;
   •   feed compounding;
   •   rendering;
   •   slaughterhouse techniques;
   •   the administrative structure of the Government Departments and local
       authorities involved;
   •   the powers available to government to regulate and enforce;
   •   the use made by government of advisory committees;
   •   basic human and animal biology;
   •   genetics; and
   •   current scientific knowledge in relation to the nature of Transmissible
       Spongiform Encephalopathies (TSEs).

35 These topics form the background to ten years of activity in response to the
emergence of BSE. We must review that activity in context. A key consideration in
an exercise as far-ranging and complex as this Inquiry is how best to present and
make widely available the significant material and findings we have assembled.
                                                                                            7
FINDINGS AND CONCLUSIONS


         36 We are conscious that while some will wish to follow, in detail, our examination
         of the BSE story, or some specific parts of it, most will not have the time or the
         energy for such an exercise. The majority will wish to read, in simple language, a
         summary account of the emergence of BSE and how it was handled, with particular
         reference to its implications for human health. More particularly, the majority will
         be looking to us to answer, as best we can, a number of questions about BSE, vCJD
         and the conduct of government in relation to them over the period with which we
         are concerned. This volume aims to meet those wishes of the majority.

         37 The emergence of BSE called for responses of different kinds and in relation
         to different areas of activity. In this volume we propose to follow a topic-based
         approach. At the outset we shall explain the nature of Transmissible Spongiform
         Encephalopathies and examine the assumption which lies at the root of this Inquiry:
         that the variant of the human disease CJD is a consequence of the emergence of
         BSE. We conclude this chapter by setting out the BSE story in a nutshell. In the next
         chapter we have included sections about the industries which feature in the BSE
         story; how government was set up to handle an issue like BSE; and handling risk.
         We aim in that chapter to give much of the background that will enable the reader
         to follow the story in the rest of this volume.

         38 Chapters 3 to 6 contain a narrative of a part of the BSE story which, for the most
         part, has been in the public eye:

            •   the emergence of BSE;
            •   the theories as to its cause;
            •   the measures taken to try to eradicate it;
            •   the concerns that humans might be able to catch BSE and worries about the
                safety of beef;
            •   the official reassurances about the risk to humans and the safety of beef; and
            •   the dreadful discovery that BSE had probably been transmitted to humans
                after all.

         39 In Chapters 7 to 9 we turn to parts of the story of which the public was generally
         not aware at the time. As a result of recent media coverage, the subject matter of
         Chapter 7 – steps taken to address the possibility that BSE might have infected
         medicines, vaccines and cosmetics that used bovine products as ingredients or in the
         manufacturing process – has now become public. But Chapters 8, 9 and 10 deal with
         the less familiar topics of guidance given to occupational groups which may have
         been at risk from handling potentially infected tissues at work; the consideration
         given to tracing all the uses of bovine tissue and thus all possible pathways along
         which infection may have been transmitted; and the impact of BSE on pollution and
         waste control. In Chapter 11, we summarise our main findings about the part played
         by the Territorial Departments, as they then were, in Wales, Scotland and
         Northern Ireland.

         40 In Chapter 12 we set out the conclusions we have been able to draw about the
         scientific response to BSE, dealing with some important questions, such as the
         origin of the BSE agent.
8
                                                                                                                          INTRODUCTION


41 We conclude with two chapters which fulfil what we believe to be the essence
of our remit, that is, to understand why things happened in the way they did and to
suggest how lessons may be learned from the BSE story for the benefit of those
facing similarly difficult situations in future.

42 In summarising our findings and conclusions in a manner and at a length which
we hope will make them accessible to all, we have had to paint with a broad brush
and to leave untouched some parts of the gigantic canvas. The picture is painted in
greater detail in the remaining 15 volumes, starting with Volume 2, which contains
an analysis of the scientific evidence. Volumes 3 to 9 contain a detailed description
and analysis of the events which are summarised in this volume.

43 Volume 10, which is a background volume, describes the impact of BSE on the
economy and looks at how international trade was affected. Before BSE emerged,
the majority of exports from the UK, of both live cattle and beef, went to the
European Union (EU).4 After BSE emerged, these exports were subjected to
restrictions that were imposed under European law. They did, however, benefit
from the protection of the Single European Market, which made it unlawful for
individual members of the EU to impose more stringent requirements on UK
exports. Our Terms of Reference require us to consider the response to the
emergence of BSE in the UK. We have not traced the deliberations that took
place in Europe – in which representations of the UK played a key role – which
determined the extent of the restrictions consequent upon BSE that were placed on
our trade with the EU.

44 So far as the export of live cattle was concerned, the EU response was to restrict
this to cattle of a BSE-free provenance which, after 1990, were aged less than six
months. So far as beef was concerned, exports were restricted to beef on the bone
of a BSE-free provenance, or beef off the bone from which all obvious nervous and
lymphatic tissue had been trimmed. From December 1994 there were exemptions
in respect of beef from younger cattle.

45 Statistics of exports of cattle and beef during the period with which our Inquiry
is concerned are set out in Chapter 5 of Volume 10. They make interesting reading.
Despite the EU restrictions, our exports of live cattle to the EU climbed steadily
between 1988 and 1994, dropping only slightly in 1995. Outside the EU, sales of
live cattle slumped to negligible proportions after 1989. The value of exports of beef
on and off the bone to the EU climbed by 1995 to well over double their value in
1987. Outside the EU, sales of beef off the bone slumped between 1986 and 1993,
before recovering to close to previous levels. Sales of beef on the bone reduced to
negligible proportions after 1987.

46 Volume 11 looks at the important role in the BSE story played by scientific
committees and independent scientists. It forms the basis for a large number of
lessons to be learned about the use of expert scientific committees which are set out
in the final chapter of this volume.

47 The factual parts of these volumes have been based in large measure on ‘draft
factual accounts’, which were collated from the evidence, were published as the
4
    The European Union (EU) came into existence on 1 November 1993 as a result of the Maastricht Treaty. It incorporated
    but did not replace the European Community. Throughout the volumes of this Report, the term EU is generally used for
    consistency’s sake (even if sometimes chronologically incorrect), except where specific reference is made to the functions
    conferred by the European Community Treaty or to its legal effect                                                            9
FINDINGS AND CONCLUSIONS


         Inquiry progressed, and have been revised on the basis of comments received and
         additional evidence. To these we have added, in Volumes 2 to 9 and 11, sections of
         comment and discussion in which we have considered conflicts of evidence and
         explained the conclusions that we have drawn from the facts. Readers who want
         detailed explanations for the findings and conclusions set out in this volume will
         find them in those volumes. They will also find an abundance of references to
         source material, which will remain accessible to the public. In this volume we have
         sought to keep references to a minimum.

         48 Volumes 10 and 12 to 15 contain background material which provides a detailed
         context in which the BSE story is set. Volume 16 contains relevant reference
         material. It should be noted that Volumes 10 and 12 to 16 are background volumes
         which have been prepared by researchers on the Inquiry team under our supervision
         and guidance. Conclusions of the Committee are not to be found in these volumes.

         49 It has been clear that speedy access to Inquiry material through the Internet has
         been widely appreciated, and we have therefore cast and referenced our Report and
         its supporting material in a form immediately transmissible through this medium.
         We hope that it will thus prove another example of open practice on matters of
         legitimate public concern.



         Transmissible Spongiform Encephalopathies

         50 Our Terms of Reference speak of two diseases: BSE, a disease of cattle; and
         variant CJD, a human disease. These are varieties from a rare group of diseases
         known as Transmissible Spongiform Encephalopathies (TSEs). TSEs cause the
         appearance of microscopic holes in the brain, giving it a sponge-like appearance –
         hence the term ‘spongiform’. They are invariably fatal and affect both humans and
         animals. In 1986 a number of TSEs had been identified both in animals – scrapie
         in sheep and goats, Chronic Wasting Disease (CWD) in wild deer in North America
         and Transmissible Mink Encephalopathy (TME); and in humans –
         Creutzfeldt-Jakob Disease (CJD), Gerstmann-Sträussler Syndrome (GSS), kuru and
         Fatal Familial Insomnia (FFI). Although a signal feature of these diseases is that
         they are transmissible in the manner described in paragraph 52 below, they can
         occur, at least in humans and probably in other species, as a result of a genetic
         mutation that is inherited or, in some cases, that may arise spontaneously.

         51 When BSE was first identified, the nature of the infectious agents causing TSEs
         was a matter of controversy. It was known that the agents were extremely difficult
         to inactivate – they could withstand treatments commonly used to disinfect virus-
         contaminated materials – and that researchers had failed to detect an immune
         response in hosts to their presence in a variety of experiments. Although these
         features suggested that TSEs were not caused by conventional viruses, some
         believed that they must be caused by an unconventional virus. This belief was
         challenged by those who thought that TSEs were transmitted as a result of a
         reaction between proteins. This theory has now won general, though not
         universal, acceptance.

         52 How, under this theory, does transmission of these diseases occur? Let us take
10       BSE as an example. The building blocks of every animal, including the human
                                                                                                                            INTRODUCTION


animal, are proteins. These are minute particles which have different chemical
compositions. BSE involves the deformation of one of these proteins (prion
protein)5 in very large numbers within the brain of the cow, until the brain develops
a spongy appearance and is fatally damaged. The same deformation of this protein
takes place in other specific tissues in the cow. If some of the deformed proteins of
an animal suffering from BSE are introduced into the body of another animal or into
a human (‘the host’), they may induce similar proteins that are found in the host to
deform in the same way. By a kind of chain reaction, deformation of these proteins
may spread to and within the brain of the host, until finally the brain is so damaged
that the host is taken ill and dies.

53 The prion protein exists in its normal form in all animals, but its chemical
composition is not precisely the same in each. It can even have slight variations in
animals of the same species as a result of minor variations of the prion gene. The
more similar the prion protein in infected animals to that in the host animal, the
easier the transmission of a TSE appears to be. Thus transmission is easiest between
animals of the same species. When the animals are of different species, the ‘species
barrier’ will sometimes prevent transmission altogether.

54 The obvious way in which deformed protein from an animal incubating a
TSE may be introduced into another animal is as food. There are, however, other
possibilities. For instance, medical products administered by injection are
sometimes derived from animal tissues or fluids. Experiments have shown that it is
very much easier to transmit a TSE to an animal by injecting infected tissue directly
into the brain than by feeding it to the animal. A minute quantity will suffice for
such intracerebral transmission; indeed CJD has sometimes been transmitted on
surgical instruments used in neuro-surgery despite their sterilisation.



Transmission to humans

55 The two most worrying questions people ask about BSE are:

    •     Is it certain that the victims of the variant form of CJD have caught BSE?
    •     And, if so, how many victims are there likely to be?

56 We shall here summarise our conclusions about the link between BSE and
vCJD, which are the subject of more detailed coverage in vol. 2: Science and in
vol. 8: Variant CJD.

57 The unusual clinical features and novel pathology of the early cases of CJD in
young people suggested this was a new variant of the disease. Much experimental
work has been done to investigate whether there is a link between this new variant
of CJD and BSE, and we believe there is now sufficient evidence to be confident
that vCJD is caused by the transmission of BSE to humans. In outline, the main
evidence, in addition to the temporal and geographical association of the two
diseases, which leads us to reach this conclusion is as follows:


5
    Professor Stanley Prusiner, who coined the term ‘prion protein’ and who was awarded a Nobel prize for his work in this field,
    assisted us with a presentation of the prion theory in Phase 1 of the Inquiry                                                   11
FINDINGS AND CONCLUSIONS


         i. in strain-typing studies in both mice and primates the disease patterns
            (incubation period and disease pathology) of BSE, vCJD, feline spongiform
            encephalopathy (FSE) and TSEs of exotic ruminants were shown to be
            extremely similar,6 while differing from those of scrapie and sporadic CJD;
         ii. patterns known as glycosylation patterns, produced by analysing samples of
             brain using a technique called western blotting, are the same for BSE and vCJD.
             The patterns for BSE and vCJD are different from those for other TSEs such as
             sporadic CJD and iatrogenic CJD; and
         iii. in transgenic mice in which the mouse prion gene has been replaced by the
              bovine prion gene, inoculation with tissue derived from BSE-infected cattle
              produces the same disease pattern and incubation period as inoculation with
              tissue derived from patients with vCJD.

         58 It is not possible to say whether BSE was transmitted to humans through
         consumption of beef or beef products, or by some other means; nor is it possible to
         say when individual infection occurred. There are a number of other unanswered
         questions:

             •     Why does vCJD affect young people? Possible explanations meriting further
                   investigation include: the possible disproportionate consumption by young
                   people of beefburgers, some of which contained high-risk material; higher
                   incidence of infections such as tonsillitis or gastroenteritis in children
                   than adults, giving rise to transmission through broken skin or mucous
                   membranes; infection through gum lesions associated with eruption of teeth;
                   and transmission via childhood vaccines prepared in cultures containing
                   bovine constituents.
             •     How many more people will succumb to vCJD? To attempt to answer this
                   question is not required by our Terms of Reference, nor would we feel able
                   to do so. Estimates of the possible size of a vCJD epidemic are made difficult
                   by the many variables associated with the disease. Many important factors
                   in determining the likelihood of BSE transmission to an individual are
                   unknown, such as dose, route of exposure, incubation period, genetic
                   susceptibility and scale of the species barrier between cattle and humans.
                   Nevertheless, several groups of epidemiologists and statisticians have
                   attempted to predict the possible number of cases. Projections have in the
                   past ranged from small numbers to many millions and it is not possible at this
                   stage to reach a firm estimate.
             •     Is occupation a risk factor in vCJD? Among occupational groups exposed to
                   BSE, to date farmers are the only group to have an excess over the incidence
                   of CJD for the population as a whole. Between 1990 and 1996 four cases of
                   CJD occurred in farmers who were known to have had cases of BSE on their
                   farms. In addition, two farmers’ wives succumbed to CJD. The affected
                   farmers were aged between 54 and 64 and had signs and symptoms typical
                   of sporadic CJD. They did not have glycosylation patterns associated with
                   vCJD. To date, no one has demonstrated a link between these cases and BSE.




12       6
             It is thought that domestic cats caught FSE and exotic ruminants a related TSE through the consumption of BSE-infected food
                                                                                   INTRODUCTION


The story in a nutshell

What happened?

59 This is a summary of the more significant events in the BSE story. In responding
to the emergence of BSE, the Ministry of Agriculture, Fisheries and Food (MAFF)
and the Department of Health (DH) took the lead. For the most part, Wales,
Scotland and Northern Ireland followed that lead. This summary will focus on the
action taken by MAFF and DH.

60 A TSE known as scrapie has been endemic in the sheep population of the UK
for nearly 200 years. In the later stages of the disease the fabric of the brain is
attacked. The pathologist can diagnose the disease by the spongiform appearance
of the diseased brain. At the end of 1986 pathologists at the Central Veterinary
Laboratory (CVL) identified similar degenerative changes in the brain samples
of diseased cattle from two different herds. These were early cases of BSE.

61 By May 1987 this novel disease had been confirmed in four herds. No publicity,
even within the State Veterinary Service (SVS), had been given to these early cases
and it is likely that others had gone unrecognised and unreported. From May,
however, the fact of the existence of a novel disease was gradually disseminated and
Mr John Wilesmith, head of the CVL’s Epidemiology Department, was asked to
investigate its cause.

62 Over the next six months, as he carried out his task, reported incidents of the
disease proliferated. By 15 December 1987 there were 95 confirmed cases on 80
farms. Mr Wilesmith had formed the provisional view that the cause of the outbreak
was contaminated meat and bone meal (MBM) that had been incorporated in cattle
feed. His confidence in this theory grew stronger early in 1988, and he concluded
that the likely contaminant was offal of scrapie-infected sheep, rendered down to
make MBM. Enquiries of feed compounders tended to confirm this view.

63 On 18 May 1988 Mr John MacGregor, the Minister of Agriculture, on the
advice of Mr William Rees, the Chief Veterinary Officer (CVO), decided on what
proved to be the principal step taken to eradicate BSE. A prohibition on feeding
ruminant protein to ruminants (‘the ruminant feed ban’) was introduced on 14 June
1988 to take effect on 18 July. This was, at the time, regarded as a measure to protect
animal health. The risk that BSE posed to human health had not, however,
been ignored.

64 Officials at MAFF had been concerned from the outset at the possibility that
BSE might pose a risk to human health. Diseased cattle were going into the human
food chain. Scrapie was not transmissible to humans, but there was no certainty that
the same would be true of BSE. By 19 February 1988, 264 cases of BSE from
223 farms had been confirmed. On 24 February Mr Derek Andrews, the Permanent
Secretary, forwarded a submission to Mr MacGregor. This recommended that BSE
should be made a notifiable disease and that a policy of compulsory slaughter with
compensation should be introduced. Mr MacGregor had reservations about such a
policy and accepted the suggestion that the advice of Sir Donald Acheson, the Chief
Medical Officer (CMO), should be sought on the implications that BSE had for
human health.                                                                             13
FINDINGS AND CONCLUSIONS


         65 Sir Donald, in turn, recommended that an expert working party should be set up
         to advise on the implications of BSE. This was done. The Working Party was
         chaired by Sir Richard Southwood.

         66 Before the first meeting of the Southwood Working Party, and at the same time
         that the ruminant feed ban was introduced, Mr MacGregor, on the advice of his
         officials, introduced a requirement for compulsory notification of all cases of BSE.

         67 On 21 June 1988 the Southwood Working Party made interim recommendations
         that included the compulsory slaughter of animals showing symptoms of BSE and
         the setting up of a committee to advise on research. The Government accepted these
         recommendations and, on 8 August 1988, an Order came into force making
         slaughter of BSE suspects compulsory. Compensation of 50 per cent of the sound
         value of the animal was paid if, on post-mortem, it was shown to have had BSE and
         100 per cent if it did not. Although made under the Animal Health Act 1981, the
         primary object of this measure was to take sick animals out of the human food chain.

         68 By 13 January 1989, 2,296 cases of BSE had been confirmed on 1,742 farms.

         69 The Southwood Report was submitted to Ministers on 9 February 1989. This
         endorsed Mr Wilesmith’s conclusion that the source of infection was probably
         scrapie-infected meat and bone meal. It concluded that it was ‘most unlikely that
         BSE would have any implications for human health’. It recommended that the
         Health and Safety Executive (HSE) and the authorities responsible for human and
         veterinary medicines, which had already been alerted by the Working Party, should
         take appropriate measures to address possible risks posed by BSE, and advised
         manufacturers of baby foods not to include in their products ruminant offal
         including thymus, which, from what was known about scrapie, would be most likely
         to be infective. Sir Richard Southwood clarified later in February that this offal did
         not include liver or kidney.

         70 The Working Party concluded that the risk posed by BSE-infected animals
         which had not yet developed clinical signs did not justify any further measures to
         protect human food. The Government accepted this, and on publication of the
         Southwood Report announced that secondary legislation would make it illegal to
         sell baby food containing the types of offal identified by the Report. MAFF
         Ministers, however, had concerns which, after discussion with officials and with
         DH and after wide consultation, led, on 13 November 1989, to the introduction of a
         ban on the use for human consumption of Specified Bovine Offals (SBO), namely
         those tissues in cattle considered most likely to be infective. This became known as
         ‘the human SBO ban’. Tissues from cattle aged under six months were exempt from
         the ban on the basis that scrapie infectivity had not been found in lambs of this age.

         71 Meanwhile, on 27 February 1989, the establishment of a committee chaired by
         Dr David Tyrrell was announced. The Tyrrell Committee was to advise on research
         in relation to BSE, thus implementing one of the first recommendations of the
         Southwood Working Party. This Committee met three times and delivered to the
         Minister of Agriculture and the Secretary of State for Health what they described as
         an ‘Interim Report’ on 13 June 1989. This identified the key research questions that
         needed to be answered and set in an order of priority the research studies needed to
         answer those questions.
14
                                                                                   INTRODUCTION


72 The Report was not published until 9 January 1990. By this time funding had
been put in place which enabled the Food Minister, Mr David Maclean, to announce
that all projects identified by the Tyrrell Committee as ‘urgent’ or of ‘high priority’
had either been put in train or would start as soon as possible. Experiments to check
the belief that BSE was transmissible had been put in hand at an early stage. In
September 1988 transmission to mice by intracerebral inoculation of brain tissue
had been confirmed. By February 1990 transmission to cattle had been established
by the same route and transmission to mice by oral ingestion had been achieved.

73 Meanwhile, on 28 July 1989, the EU banned the export of UK cattle born before
18 July 1988 and of offspring of affected or suspect females. This was the first of a
number of restrictions placed by the EU on the export from the UK of live cattle and
(from June 1990) of beef.

74 By the end of 1989, 10,091 cases of BSE had been confirmed in the UK.

75 Anxiety had been expressed in many quarters that 50 per cent compensation
might be inadequate to procure full compliance with the requirement to notify
BSE suspects and, on 14 February 1990, Mr John Gummer, who had succeeded
Mr MacGregor as Minister of Agriculture, introduced entitlement to 100 per cent
compensation.

76 On 1 March 1990 the EU restricted exports of live cattle to those aged less than
six months. Importing Member States were required to ensure that these were
slaughtered before they reached that age. Offspring of whatever age of affected or
suspected females continued to be banned from export.

77 On 3 April it was announced that Dr Tyrrell was to chair a new expert
committee – the Spongiform Encephalopathy Advisory Committee (SEAC).
The Committee had a wider membership than the Tyrrell Committee and wider
terms of reference:

       To advise the Ministry of Agriculture, Fisheries and Food and the
       Department of Health on matters relating to spongiform encephalopathies.

78 It was government policy in relation to BSE to act on ‘the best scientific advice’.
Thereafter the Government was to look to SEAC to provide that advice.

79 One of the recommendations of the Southwood Working Party had been the
need for surveillance of CJD cases in order to detect whether there were any
changes in their incidence that might be attributable to BSE. In May 1990 the CJD
Surveillance Unit was set up under Dr Robert Will, a consultant neurologist at the
Western General Hospital in Edinburgh.

80 On 10 May 1990 it was announced that a Siamese cat had died of a spongiform
encephalopathy – the first known case of feline spongiform encephalopathy (FSE).
This resulted in a rash of media comment, speculating that the cat had caught BSE
and that humans might be next. Humberside Education Authority had already
banned beef from school meals and a number of other Authorities threatened to
follow this example. Public statements by the CMO and by Mr Gummer that beef
was safe to eat failed wholly to reassure. The House of Commons Agriculture
Committee announced an Inquiry into BSE. After receiving evidence from most of            15
FINDINGS AND CONCLUSIONS


         the key players in the BSE story, the Committee reported on 12 July 1990 that, while
         there were too many unknowns to say anything with absolute certainty, ‘we heard
         no evidence of any sort to constrain those taking a more balanced view of the risks
         from eating beef’. The measures taken by the Government ‘should reassure people
         that eating beef is safe’.

         81 On 8 June 1990 the EU Council of Ministers agreed that bone-in beef exported
         from the UK must come from holdings where BSE had not been confirmed in the
         previous two years, while boneless beef was required to have obvious nervous and
         lymphatic tissue removed.

         82 Meanwhile, there had been controversy as to whether the SBO that had been
         banned from human food should be permitted to be fed to animals. Pet food
         manufacturers had voluntarily ceased to incorporate it in their products. UKASTA,
         the feed producers’ trade association, had pressed strongly for a ban on including
         SBO in the material rendered to make MBM for inclusion in pig and poultry feed,
         and advised their members to exclude it. MAFF officials and Ministers opposed a
         ban on the ground that it was without any scientific justification. SEAC was about
         to advise on this question when, early in September, a pig, which had been
         inoculated with BSE-infected brain tissue, succumbed to the disease. In an
         emergency meeting SEAC advised that, as a precautionary measure, SBO
         should not be fed to any animals. MAFF, which had anticipated this possibility,
         immediately banned the incorporation of SBO or its products in animal feed
         (‘the animal SBO ban’). Export of feed containing SBO to the EU was also banned.
         This was followed in July 1991 by a ban on the export of material derived from SBO
         to third countries.

         83 Among the many matters on which SEAC was asked to advise were
         slaughterhouse practices. There was concern that the removal of brain and spinal
         cord (both SBO) in slaughterhouses might contaminate meat going for human
         consumption. There was also concern about the practice of the mechanical recovery
         of remnants of meat and other tissues adhering to the vertebral column, in that these
         might include scraps of spinal cord not cleanly removed by slaughterhouse
         operators. SEAC advised that head meat should be removed before brain, but that
         no further measures were necessary provided that the rules were properly followed
         and supervised. This advice was implemented first by guidance and then, in
         March 1992, by statutory regulation.

         84 By the end of 1990, 24,396 cases of BSE had been confirmed in the
         United Kingdom.

         85 One of a number of recommendations of the House of Commons Agriculture
         Committee was that the Government should ‘establish an expert committee to
         examine the whole range of animal feeds and advise on how industries which
         produce them should be regulated’. Some debate ensued as to how to implement this
         recommendation, but on 6 February 1991 MAFF announced the establishment of an
         Expert Group on Animal Feedingstuffs chaired by Professor Eric Lamming. It met
         on 14 occasions over the next year and reported on 15 June 1992. The Group
         considered the steps taken to prevent the BSE agent being transmitted to animals in
         feed and concluded that they were satisfactory and adequate. In particular the Group
         considered whether the practice of feeding animal protein to animals should be
16
                                                                                   INTRODUCTION


discontinued. It decided that there was no scientific justification for such a step.
It did, however, recommend that:

          . . . an independent Animal Feedingstuffs Advisory Committee be
          established to take an overview of all feedingstuffs issues.

86 Although the Government initially accepted this recommendation, it
subsequently decided not to proceed with it.

87 With compulsory slaughter of sick animals and the human SBO ban to deal with
potentially infective tissues in apparently healthy animals incubating BSE, the
Government considered that there were in place appropriate measures to deal with
the risk that BSE might be transmissible to humans in food. Action was taken to see
that medicinal products both for humans and for animals were not sourced from
potentially infective bovine tissues. Ruminants were protected by the ruminant feed
ban and other animals by the animal SBO ban. No further major measures were
considered necessary to protect human or animal health in the period with which we
are concerned. In March 1992 SEAC concluded ‘that the measures at present in
place provide adequate safeguards for human and animal health’. Several relatively
uneventful years were to pass before it became apparent that the measures in place
were not achieving all that had been expected of them.

88 Because of BSE’s lengthy incubation period, it was appreciated when
introducing the ruminant feed ban that years would pass before it would have a
visible effect. What was not known was the rate at which cattle had been infected in
the period up to 18 July 1988, when the ruminant feed ban came into force. At the
time of the Southwood Report suspected cases of BSE were being reported at the
rate of about 400 a month. It was considered that these had been infected with
scrapie and that this source would have continued to infect cattle until the ban at
about the same rate. Whether, or to what extent, recycling of BSE might have
increased the rate of infection was not known.

89 It soon became apparent from the numbers of BSE cases reported7 that the rate
of infection had not reached a plateau, but had been increasing rapidly in the years
leading up to the ruminant feed ban, and that the reason for this was the effect of
recycling the BSE agent in MBM.

90 Thus the Government found it had to deal with many more cases infected before
the ban than it had expected. But of even more concern were cases in cattle that had
been born after the ban (BABs). The first of these was announced on
27 March 1991.

91 When exploring the possible sources of infection of the BABs, the CVL
epidemiologists were able to rule out maternal transmission in most cases. The
likely source of infection of the earlier BABs was thought to be ruminant feed in
which ruminant protein had been incorporated before the ban and which was in the
distribution pipeline, or still unused on farms when the ban came into force.
This remained the view of MAFF officials at the beginning of 1994, by which time
Mrs Gillian Shephard had succeeded Mr Gummer as Minister of Agriculture.
Cross-contamination of ruminant feed by non-ruminant feed in the feedmills was

7
    For statistics, see vol. 16: Reference Material                                       17
FINDINGS AND CONCLUSIONS


         considered, but discounted after September 1990, when the animal SBO ban should
         have prevented SBO from being incorporated in any animal feed.

         92 In the course of 1994 opinions changed as to the source of infection of BABs.
         By August the CVL had reached the conclusion that the more recent BABs had been
         infected by feed which had been contaminated in the feedmill by feed containing
         ruminant protein. Two factors had led to this conclusion. First, there had been an
         increasing volume of evidence, some of it cogent, of widespread infringement of the
         animal SBO ban, so that SBO was contaminating non-ruminant feed. Second,
         interim results of an experiment, which started in 1992, indicated that a single
         quantity of as little as 1 gram of infective material – the size of two peppercorns –
         had sufficed to infect cattle to which this had been fed.

         93 MAFF officials approached the problem of the cross-contamination of
         cattle feed on two fronts. Their primary emphasis was on tightening up the
         implementation of the animal SBO ban. This was facilitated by the transfer of
         enforcement functions in slaughterhouses to central government. What had been the
         responsibility of some hundreds of individual local authorities became the task of a
         new national Meat Hygiene Service (MHS) from 1 April 1995. A revised statutory
         scheme was introduced that required SBO to be identified by a distinctive blue dye
         and kept separate at all times from other material. At the same time plants rendering
         SBO were required to do so in separate facilities. The consultation process was
         thorough and lengthy, with the result that the introduction of the new Regulations
         was not completed until August 1995. Their introduction was combined with a
         campaign of more rigorous enforcement and monitoring of the Regulations by the
         MHS and the Veterinary Field Service (VFS).

         94 At the same time as tightening up on the implementation of the animal SBO ban,
         MAFF officials took steps to address cross-contamination in feedmills. So far as
         these were concerned, effective monitoring of compliance with the ruminant feed
         ban had been initially impossible for want of any method of testing for the presence
         of ruminant protein in animal feed. It had been hoped that an ‘ELISA test’ would be
         perfected within about 12 months, capable of detecting this. In the event, it was not
         until 1994 that the test was ready for use, and even then its results were not
         sufficiently reliable to provide evidence that would support a prosecution for breach
         of the Regulations. The test was, however, employed on a voluntary basis, with
         cooperation from UKASTA, and resulted in at least some feedmills taking steps to
         reduce the possibility of cross-contamination.

         95 Hindsight confirms that, between 1989 and 1994, the ruminant feed ban had
         resulted in a steady but substantial year-on-year reduction in the numbers of
         infections, and that the measures taken in 1994 and 1995 radically accelerated this
         decline (see Volume 16, Figures 3.2 and 3.34).

         96 The years 1994 and 1995 also saw developments in relation to the risks posed
         by BSE to human health. An interim result of a pathogenesis experiment conducted
         by the CVL demonstrated infectivity in the distal ileum (small intestine) of a calf
         within six months of oral infection with BSE. This led MAFF, with the agreement
         of DH, to extend the human SBO ban to include the intestines and thymus of calves
         which had died aged over two months.

18
                                                                                  INTRODUCTION


97 On 27 July 1994 the European Commission decided that existing restrictions on
the export of UK beef should be replaced with two measures. One was a ban on
export of bone-in beef except from cattle which had not been on holdings where
BSE had been confirmed in the previous six years. The other measure affected beef
from cattle which had been on such a holding within that time. This could not be
exported unless it was deboned with adherent tissues removed. In December 1994
the Commission amended this decision to exempt from these measures beef from
cattle born after 1 January 1992. Subsequently in July 1995 this exemption was
replaced with one that exempted beef from cattle less than 30 months of age
at slaughter.

98 In July 1994 Mrs Shephard was succeeded by Mr William Waldegrave, who
oversaw the introduction of the MHS. He in turn was succeeded by Mr Douglas
Hogg in July 1995. At the direction of Mr Hogg, the MHS set about raising
standards of meat inspection, a task that was to prove to require the employment of
several hundred additional staff.

99 More rigorous monitoring of slaughterhouses in 1995 disclosed a number of
occasions on which Meat Inspectors had applied the health stamp to a carcass to
which fragments of spinal cord remained attached. This led SEAC to recommend a
ban on the practice of extracting mechanically recovered meat (MRM) from the
spinal column of cattle. MAFF accepted that advice and introduced the ban in
December 1995.

100 In the course of 1995 a number of events served to increase public anxiety that
it might be possible to contract CJD as a consequence of eating beef. Cases of CJD
were reported in farmers whose herds had had BSE and in several young people –
the latter being particularly significant because up until then the disease had almost
invariably struck down its victims late in life. A distinguished scientist questioned
the safety of beef offal. These events received wide media coverage. The CMO and
the Secretary of State for Health each responded with public assurances that it was
safe to eat beef.

101 The first two months of 1996 saw the CJD Surveillance Unit and SEAC
concerned at an increasing number of young victims of CJD. On 16 March SEAC
advised the Government that a new variant of CJD had been identified in young
people and that the most likely explanation was that these were linked to exposure
to BSE before the introduction of the SBO ban in 1989. A series of urgent meetings
of Ministers and then of the Cabinet ensued, and SEAC’s advice was sought as to
further precautionary measures.

102 On 20 March 1996 the Government announced the likelihood that the recent
cases of CJD in young people had resulted from exposure to BSE before 1989 and
stated its intention to adopt further precautionary measures in accordance with
SEAC’s advice. These were that carcasses from cattle aged over 30 months must be
deboned and that the use of MBM in feed for all farm animals would be banned.
These measures proved inadequate to reassure the public and, within two weeks,
were replaced with a total ban on cattle over the age of 30 months being used for
human food or animal feed.

103 By 20 March 1996 approximately 160,000 cattle affected by BSE had been
slaughtered. In addition about 30,000 cattle suspected of BSE, but not confirmed to      19
FINDINGS AND CONCLUSIONS


         have the disease, were slaughtered. These figures can be compared with over
         3.3 million cattle slaughtered and destroyed under the Over Thirty Month Scheme
         in the period from March 1996 to the end of 1999.

         104 This brief narrative has concentrated on events that have been most in the
         public eye. As we explained above, we shall also cover in later chapters of this
         volume precautionary measures taken in areas which, while important, did not come
         to the attention of the general public. These include medicines, cosmetics and
         occupational health.

         Why did it happen?

         105 The Report of an Inquiry such as this inevitably focuses on the areas where
         things went wrong. It is those areas that government and the public are most anxious
         to have thoroughly explored. For this reason we think it desirable to give at the
         outset an overview of why things happened in the way that they did.

         106 Why initially a cow or cows developed BSE will probably never be known.
         Why the early case or cases began a chain of transmission that ended with hundreds
         of thousands of cattle becoming infected is now clear. It was because of the practice
         of rendering cattle offal, including brain and spinal cord, to produce animal protein
         in the form of meat and bone meal (MBM), and including MBM in compound cattle
         feed. This resulted in the recycling and wide distribution of the BSE agent.

         107 Many have expressed the view that it was not surprising that a practice as
         unnatural as feeding ruminant protein to ruminants should result in a plague such as
         BSE. Had BSE emerged soon after this practice was introduced, there might have
         been force in this reaction. However, the practice of feeding MBM to animals in the
         UK dates back at least to 1926, when it was given statutory recognition in the
         Fertilisers and Feedingstuffs Act of that year. It is a practice which has also been
         followed in many other countries. It was recognised that it was important that the
         rendering process should inactivate conventional pathogens. Experience had not
         suggested that the practice involved any other risks. In these circumstances we can
         understand why no one foresaw that the practice of feeding ruminant protein to
         ruminants might give rise to a disaster such as the BSE epidemic. Accusations have
         been made both against the Government and against renderers of causing BSE by
         relaxing rendering standards. As we shall explain, changes in rendering practices
         and regulatory requirements are unlikely to have made any substantial difference.

         108 There were a number of factors that made it inevitable that, whatever measures
         were taken in response to its emergence, BSE would be a tragic disaster:

            •   it had an incubation period of five years on average;
            •   it tended to strike a single cow in a herd;
            •   it had clinical signs which were similar to those of a number of other diseases
                in cattle;
            •   it was impossible to diagnose before clinical signs appeared; and
            •   it was transmissible to human beings, but with a much longer incubation
                period than that in cattle.
20
                                                                                   INTRODUCTION


109 These factors had the following consequences:

    •    the emergence of the disease may well have gone undetected for ten years or
         more from the time of the first cases. A farmer would not be likely to send a
         single casualty for a post-mortem. It was only when, by chance, several cases
         were experienced on the same farm that the pathology was carried out that
         disclosed the new disease;
    •    by the time that BSE was identified as a new disease, as many as 50,000
         cattle are likely to have been infected;8
    •    it is also likely that by this time some of the human victims had been
         infected;
    •    it was not until nearly ten years after BSE was identified as a new disease in
         cattle that the first human victims succumbed to the disease, thus showing
         that, contrary to expectation, it was transmissible to humans.

110 Given the practice of pooling and recycling cattle remains in animal feed, this
sequence of events flowed inevitably from the first cases of BSE. It was inevitable
that, whatever measures were taken, many thousands of cows would succumb to the
disease in the years to come. It was inevitable that if humans were susceptible to the
disease, some would be infected with it before its existence was even suspected.

111 The measures that were taken in response to the emergence of BSE greatly
reduced the scale of the disaster. The MBM component of feed was diagnosed as
the vector responsible for the disease with commendable speed, and the ruminant
feed ban was a swift and appropriate response. That ban reduced the rate of infection
by 80 per cent overnight and established a diminishing trend which would,
ultimately, have resulted in the eradication of the disease. Unhappily, as the cases
born after the ban were to demonstrate, there were shortcomings in formulating and
carrying out both the ruminant feed ban and the animal SBO ban, which should
have provided a second line of defence against infection of cattle feed. These
shortcomings had serious consequences. Over 41,000 cattle that developed clinical
signs of BSE in the years that followed were infected after the ruminant feed ban
came into effect. Many more must have been infected but slaughtered before the
signs developed. When the link between BSE and the new variant of CJD became
apparent in March 1996, the Government was unable to demonstrate that the source
of infection had been completely cut off. Had they been able to do so, some of the
drastic measures that followed might have been avoided. The reasons for these
shortcomings receive detailed consideration in our Report.

112 There is a popular misconception that the Government did nothing to protect
the public against the risk BSE might pose to human health until the likelihood of
transmissibility was demonstrated in 1996. It is important to emphasise that the
most significant measures to protect human health were taken at a time when the
likelihood of transmissibility to humans was considered to be remote. Those were
the compulsory slaughter and destruction of sick animals introduced in August 1988
and later, in November 1989, the human SBO ban, which was intended to remove
from the human food chain those parts of apparently healthy cattle most likely to be
infective if the animals were incubating BSE. At the same time steps were taken to
ensure that bovine ingredients of medicines came from BSE-free sources.
8
    S9 Anderson para. 1                                                                   21
FINDINGS AND CONCLUSIONS


         113 These were vitally important measures. For a period of nearly ten years
         continuous consideration was given to addressing the possibility that BSE might be
         transmissible to humans, although few believed that there was any likelihood of it.
         This is a matter for commendation.

         114 Yet again, however, there were shortcomings: shortcomings which led to
         delay in introduction of the precautionary measures, and shortcomings in
         formulating and carrying out the ban. Despite the SBO ban, some potentially
         infective bovine tissues continued to enter the human food chain. The reasons for
         these shortcomings also receive detailed consideration in our Report.

         115 The other casualty of the BSE story has been the destruction of the credibility
         of government pronouncements. Those responsible for public pronouncements – or
         at least some of them – were aware of the possibility that humans might have
         become infected before the slaughter policy and the SBO ban were introduced.
         They saw no reason to draw attention to this. They believed that the measures taken
         had effectively removed the ‘theoretical risk’ of infection. They were concerned
         that the public should not be misled by scaremongers or the media into believing
         that it was dangerous to eat beef when this was not the case. Ministers and, on
         occasion, the Chief Medical Officers, made statements about the safety of beef
         which were intended to reassure the public. Insofar as these statements were
         believed, many clearly treated them as assurances that BSE posed no danger to
         human beings. In the case of some, there was a growing scepticism as the media
         reported cases of possible human victims of BSE which were then challenged by the
         Government. When on 20 March 1996 it was announced that cases of new variant
         CJD were probably attributable to contact with BSE before precautionary
         Regulations were introduced, the reaction of the public was that they had been
         misled, and deliberately misled, by the Government.

         116 We have examined with care the public pronouncements that were made about
         the risks posed by BSE, and have concluded that allegations of a government
         ‘cover-up’ of the risks posed by BSE cannot be substantiated. There were, however,
         mistakes in the way risk was communicated to the public, and there are lessons to
         be learned from these.

         117 As we go through the story we shall describe in greater detail what happened
         and how it came to happen in the way it did. We shall consider the response to BSE
         of the individuals principally concerned in the story. At the end of this volume we
         shall review what went right and what went wrong, before turning to the lessons to
         be learned from the BSE story.




22
2. Setting the context
118 In this chapter we provide some basic information about the context in which
BSE emerged and in which people, both within government and without, had to
respond. We do this in order to assist readers in understanding the significance of
various parts of the narrative story which follows. We set out thumbnail sketches of
the industries that were principally affected by BSE and some key features of how
government works. More detailed descriptions of all these are to be found in the
background volumes. We also explain some of the concepts involved in handling
risk.



The cattle industry

119 At the time BSE emerged, beef and dairy farming was the largest sector of UK
agriculture (see vol. 12: Livestock Farming). The output from milk, fattened cattle
and calves totalled some £5 billion, nearly 38 per cent of the entire UK agricultural
output. With a cattle population of some 12.7 million, the UK produced 97 per cent
of the beef and veal required to supply the needs of the domestic market, and
sufficient liquid milk to supply 100 per cent of domestic demand for milk and
almost 70 per cent of domestic demand for butter and cheese.

120 This impressive degree of self-sufficiency was the result of the policies of
successive governments which, in the period after the Second World War, had
sought to increase domestic food production in order to reduce reliance on imported
food and to foster rural communities. Incentives to increase production levels even
further were provided in 1973, when the UK joined the European Economic
Community. The possibility of increased exports to Member States, coupled with
the support regimes of the Common Agricultural Policy (CAP), encouraged farmers
to maximise their outputs, even if this led to surplus production.

121 The increase in output from the cattle industry was achieved in a number of
ways. The most important of these was a combined breeding and feeding
programme which produced cows with a genetic capability to give high milk yields
if fed with high-protein feeds. Thus it became regular practice for farmers to
supplement the forage-based diet of cattle with protein concentrates that they would
buy from special animal feed manufacturers. The protein in these concentrates
might come from animal sources in the form of meat and bone meal (MBM),
bloodmeal, feather meal or fishmeal, or from non-animal sources, mainly in the
form of soyabean meal.

122 Although soya-derived protein may seem the more ‘natural’ option to the
layman, animal-derived protein produced as great or a greater increase in milk yield,
and its use provided an outlet for animal waste that would otherwise have had to be
disposed of in some other way. Small quantities of animal by-products had been
used in animal feed since the beginning of the 20th century. Most farmers were well
aware of the practice and had no problem with it.

                                                                                        23
FINDINGS AND CONCLUSIONS


         123 Since the purpose of protein concentrates in feed was primarily to facilitate the
         high milk yield of dairy cows, these concentrates were used more in dairy herds than
         in beef herds. Dairy calves would have protein concentrates included in their feed
         from a week after birth, whereas calves used for beef production were unlikely to
         receive concentrates until they were at least 6 months old. However, since almost
         two-thirds of beef produced in the UK originated in dairy herds, we cannot conclude
         that the cattle whose flesh we were eating had been fed less protein concentrate than
         those whose milk we were drinking.



         Slaughterhouses

         124 Cattle that were destined for human consumption had to be slaughtered in a
         licensed slaughterhouse or abattoir (see vol. 13: Industry Processes and Controls).
         Sick cattle or those that had died on the farm would instead be taken to a knacker’s
         yard or a hunt kennel and their meat and by-products would not enter the human
         food chain.

         125 In the 1980s there were around 1,000 slaughterhouses in England, Wales and
         Scotland, although this number was steadily decreasing as economies of scale and
         higher health and environmental standards pushed the smaller premises out of
         business. This decline in the number of slaughterhouses meant that more cattle had
         to travel long distances between the farm and slaughterhouse, and it was not unusual
         for the largest slaughterhouses to receive cattle from all over Great Britain.

         126 At this time the hygienic production of meat was governed in England and
         Wales by Regulations made under the Slaughterhouses Act 1974 and the Food Act
         1984. There was in fact a two-tier system of regulation that differentiated between
         plants producing meat entirely for domestic consumption and those producing some
         or all of their meat for export to other EU Member States. The regulations for export
         slaughterhouses were more wide-ranging and required a more thorough system of
         inspections.

         127 Slaughtering an animal, cutting it up and separating its constituent parts is a
         messy business however it is done. In the 1980s most large slaughterhouses had
         adopted a production-line type of procedure which enabled them to carry out the
         process as quickly as possible.

         128 In a typical large slaughterhouse animals were unloaded from lorries into the
         holding area and then moved towards the slaughter hall in single file along special
         passageways. They were then fed one by one into a pen for stunning. There were
         two methods of stunning used for adult animals. The captive bolt method involved
         firing a metal bolt into the animal’s brain, leaving a hole in its skull; the non-
         penetrative concussion method involved firing a mushroom-shaped bolt at the
         animal’s head, thus rendering the animal unconscious without penetrating its brain
         or skull. It was common practice, following captive bolt stunning, to insert a pithing
         rod into the hole in the skull in order to cause further damage to the brain and spinal
         cord, and thus to prevent the animal from kicking due to reflex muscular action.

         129 Once the animal was unconscious, its hind legs were shackled and it was
24       hoisted to an overhead rail, known as the slaughter line. Hanging with its head
                                                                              SETTING THE CONTEXT


closest to the floor, the animal could then be moved around the plant to the various
stages of the slaughtering process. It would first be moved along until it was directly
over the bleeding trough, where it would finally be killed by severing the large
blood vessels in its neck. Blood would either be allowed to pour into the bleeding
trough, or alternatively it would be sucked out through a hollow bleeding knife
attached to a vacuum pump.

130 Once bled, the carcass was moved down the line to be dressed. First the
forefeet, hind feet, udder or pizzle were removed with a knife, then the hide would
be pulled off with a powered hide puller, and after that the head would be cut off.
(Head meat would later be harvested either at the slaughterhouse or at special head-
boning plants.) Then the abdominal wall would be cut open and the internal organs
would tumble out onto the inspection table. Organs such as liver and kidneys which
would go for human consumption were separated out and sent to the ‘offal room’
for sorting. The rest of the ‘abdominal mass’ was sent, either down chutes or in
containers, to a different area known as the ‘gut room’.

131 The final stage in the process involved splitting what was left of the carcass
and removing the spinal cord. A cut would be made down the length of the spinal
column using a mechanical saw.

132 Hygiene Regulations demanded that each carcass had to be inspected by a
qualified inspector at various stages in the process in order to establish its fitness for
human consumption. Only when parts unfit for human consumption had been
removed from it could a ‘health stamp’ be applied to the carcass by the inspector.

133 Responsibility for the regulation of slaughterhouse practices was split between
the Ministry of Agriculture, Fisheries and Food (MAFF) and the local authorities
(see vol. 14: Responsibilities for Human and Animal Health). The Minister of
Agriculture, Fisheries and Food was responsible for making Regulations under the
Slaughterhouses Act 1974, and in particular had the power to make Regulations
about the construction, layout and equipment in plants. The local District Councils
or Unitary Authorities were responsible for the enforcement of these Regulations.
They issued licences to slaughterhouses and to slaughtermen, they provided the
meat inspectors, and they had the power to make byelaws (subject to confirmation
by the Minister) to ensure that slaughterhouses were kept in sanitary conditions and
were properly managed.

134 Meat and other animal by-products that were classified as unfit for human
consumption had to be disposed of within 48 hours of slaughter. Complex
Regulations prescribed how unfit meat was to be handled and much was sent direct
to renderers for processing. Unprocessed blood could be sprayed on fields as a
fertiliser, subject to the agreement of the local authority responsible for the
slaughterhouse and the licensing of the recipient farm.



Renderers

135 The rendering process involved the crushing and heating of the raw material
supplied from slaughterhouses (see vol. 13: Industry Processes and Controls). The
process led to the evaporation of the moisture in the material, which then enabled           25
FINDINGS AND CONCLUSIONS


         the fat, known as ‘tallow’, to be separated from the remaining high-protein solids,
         known as ‘greaves’. The greaves were further processed by pressing, centrifuging
         or by solvent extraction in order to remove more tallow. The resultant protein-rich
         material was then ground into meat and bone meal (MBM). In the 1980s both tallow
         and MBM had a good commercial value.

         136 Rendering is not a new industry. It has existed in some form for centuries,
         producing tallow for candles and soap. However, it was only at the beginning of the
         20th century that the production of MBM for animal feed became important. The
         production and use of MBM steadily increased throughout the first half of the
         century and, when national self-sufficiency became an important issue during the
         Second World War, Regulations actually prescribed its use in animal feed. The
         production of MBM and tallow continued to increase after the war.

         137 From the 1960s onwards there was a change in technology from older-style
         ‘batch-processing’ systems to faster and more efficient high-volume ‘continuous
         rendering’ systems. By the 1980s most plants used a continuous rendering system,
         and the economies of scale forced older and smaller plants to close down, leaving
         fewer than 100 rendering plants in England, Wales and Scotland at this time. Two
         firms dominated the market, with Prosper De Mulder processing 64 per cent of the
         red meat waste in England and Wales by the early 1990s, and William Forrest &
         Son (Paisley) processing 74 per cent of the red meat waste in Scotland.

         138 During the 1950s the process of solvent extraction became the preferred
         method of extracting tallow from greaves. The process involved pumping a
         benzene-based solvent through a heated vessel of greaves so that the tallow
         dissolved in the solvent. The tallow was then separated out from the solvent and the
         greaves were heated further so as to vaporise and remove any solvent that was still
         present. By the late 1970s this method was being phased out because of the
         increased price of solvents, the risk of fire and explosion entailed in their use, and
         because animal feed manufacturers wanted to buy MBM with a higher fat content.

         139 Up until the 1980s the rendering industry was virtually unregulated in terms
         of quality control and production methods (see vol. 14: Responsibilities for Human
         and Animal Health). In 1981 Regulations came into force to ensure the
         microbiological safety of processed protein. In the context of increasing
         deregulation by government, it was decided that the best way to do this was by
         testing the microbiological safety of the finished MBM, rather than by prescribing
         set production procedures. In effect this gave renderers a lot of freedom in
         determining their preferred production processes and it allowed for a diversity of
         processes in different plants. Advice about new Regulations reached renderers
         through the UK Renderers’ Association (UKRA), the primary trade association
         representing renderers’ interests.

         140 In the 1980s the end-products of the rendering process – MBM and tallow –
         were widely used in the manufacture of a diverse range of products. MBM was used
         as a protein source in animal feed, and in fertiliser. Tallow was used in the
         manufacture of many human foods, such as edible fats, and when further processed
         into glycerine it was used even more widely, for example in jellies and in baking. It
         was also used in animal feed and pet food, as well as in pharmaceuticals, cosmetics
         and in a range of industrial products. Meanwhile, gelatine, produced from the hide
26       and bones of animals in a completely separate industry and process, was also used
                                                                          SETTING THE CONTEXT


in a wide range of products including human food, the coatings of tablets,
cosmetics, glue, bone china and photographic chemicals.



The animal feed industry

141 In the 1980s animal feed was made up of a mixture of various constituents,
primarily cereals and cereal by-products, as well as oilseed meals, MBM and other
protein concentrates, fats, molasses, vitamins, minerals and, in some cases, small
amounts of medicinal additives. Feed manufacturers produced both ready-to-use
compound feeds and protein concentrates which farmers could use if they preferred
to mix their own feed on the farm.

142 In the early 1980s there were about 400 feed companies, although this number
was in decline. The five largest companies dominated the market, producing 54 per
cent of the UK feed output between them, while farmer co-operatives and smaller
local and regional compounders produced the rest.

143 Feedmills produced many different kinds of feeds for different animals. The
nutritional composition of the feeds was determined according to the specific
requirements of each species, and then the particular ingredients that would meet
these requirements were chosen on the basis of cost-efficiency. Medicinal additives
and growth stimulants were added when appropriate on a species-specific basis.
Some species-specific feeds were potentially dangerous to other species. Most
feedmills produced these different feeds in the same equipment. There were several
points in the manufacturing process where material could build up on or in
machinery and cause cross-contamination in the next batch. The UK Agricultural
Supply Trade Association (UKASTA) drew up a Code of Practice to try to minimise
cross-contamination of feedstuffs during the production process.



The meat industry

144 Meat that had been ‘health stamped’ as fit for human consumption in the
slaughterhouse was sent to butchers or meat processors to convert it into the forms
in which it is purchased and eaten (see vol. 13: Industry Processes and Controls).
In the post-war period processed meat products had become more popular than fresh
carcass meat, and by the early 1990s there were over 700 meat processors in the UK.
Some processed meat products contained mechanically recovered meat (MRM).
This is residual matter left attached to the bones of carcasses after the cuts of meat
have been removed. The bones are then put under high pressure so that what is left
can be stripped from them in a slurry. In the early 1980s a major source of bovine
MRM was the bovine spinal column.

145 In the fresh meat sector there had been a shift away from high street butchers
towards supermarkets as the preferred place to buy meat, and in the 1980s Tesco,
Sainsburys and ASDA between them accounted for nearly 50 per cent of retail beef
sales in the UK. One reason why supermarkets had become more popular was that
they had sought to improve the quality of their meat and meat products. They had
done this primarily through the development of quality assurance schemes which           27
FINDINGS AND CONCLUSIONS


         provided an audit trail from farm to consumer and assurance about the origin,
         husbandry and health of the cattle (see vol. 12: Livestock Farming). These schemes
         had been actively encouraged by the Meat and Livestock Commission (MLC), a
         non-departmental public body whose role was to promote greater efficiency in the
         livestock industry.



         The pharmaceutical industry

         146 Bovine materials were, and are, also used in pharmaceutical, medical and
         veterinary medical products (see Annex 1 to Chapter 2 in vol. 7: Medicines and
         Cosmetics). The UK pharmaceuticals industry is one of the largest in the world. In
         1997, for example, UK exports were worth over £5 billion and accounted for around
         12 per cent of the world market. There were over 400 pharmaceutical manufacturers
         and research organisations in the UK, although the market was dominated by
         multinationals such as Glaxo Wellcome, SmithKline Beecham and Zeneca.9

         147 Bovine materials from the slaughterhouse are used directly in
         pharmaceuticals. Several injectable medicines are derived directly from bovine
         sources. Hormones such as insulin and glucagon may be derived from bovine
         pancreases, and protein products such as aprotonin and heparin are derived from
         bovine lungs and intestinal mucous respectively. Sutures and some medical devices
         such as heart valves and pericardium patches are also derived directly from bovine
         materials, in this case the intestines, heart and serous membranes.

         148 Bovine materials are also used indirectly in the manufacture of certain types
         of vaccine. Cells which are used to grow these vaccines are nourished in nutrient-
         rich cultures that contain serum from the blood of foetal or new-born calves, or
         bovine serum albumin, which derives from the blood of older cattle. Bacterial cells
         are grown in nutrient-rich broths containing peptone derived from bovine meat, and
         some allergens are produced in special culture media which contain digests of calf
         brain and ox liver. In all these cases the bovine materials are not a constituent of the
         final product, but they are used in an ancillary way in the manufacturing process.

         149 Tallow and gelatine are also used in several pharmaceutical and medical
         products. Gelatine is widely used as a pill coating and tallow is a constituent of most
         creams and ointments.



         Other uses of bovine products

         150 Bovine materials are used in a wide range of processes and products in many
         different industries. They are used in toothpaste, chewing gum and pet food; in
         fertilisers and cosmetics; and in such varied products as fire extinguisher foam,
         buttons, handles, lubricants and racquet strings. Bovine materials are used in the
         manufacture of paint. Cattle skins are used for hides, and other bovine materials are
         included in cleaning agents used in leather processing.


28       9
             Britain 1999: The Official Yearbook of the United Kingdom, London, The Stationery Office, 1998, p. 475
                                                                          SETTING THE CONTEXT


Government and BSE

151 MAFF had lead responsibility on most BSE matters and was the ‘sponsor
department’ for those industries which found themselves implicated in the
generation and spread of the disease. This raises a question of conflict of interest
which we shall discuss later in this volume. MAFF officials took the lead on
research into the disease. Its veterinarians and scientists had particularly important
advisory roles about its causes and nature and negotiated with their counterparts
abroad about measures to control it. They had considerable national and
international stature. On a number of occasions the Chief Veterinary Officer
(CVO), or an Assistant CVO, acted as the authoritative government voice.

152 The risk from BSE to human health took matters beyond MAFF’s
departmental borders. Acting as the authoritative public voice on the safety of beef
was a role undertaken by the Chief Medical Officer (CMO) at the Department of
Health (DH), and it was the CMO who had oversight of the response within his
Department. He and his colleagues were closely involved in considering and
agreeing with MAFF measures to reduce risks to human health via food,
pharmaceuticals, occupational exposure and other pathways. They mainly relied on
advice from outside experts and committees.

153 Measures affecting most aspects of agriculture and health in Wales, Scotland
and Northern Ireland were the responsibility of Departments overseen by the Welsh,
Scottish and Northern Ireland Offices. Others directly concerned with the response
to BSE included the Health and Safety Executive (HSE), because of risks through
occupational exposure; the Department of Trade and Industry (DTI) as sponsor
Department for the cosmetics and toiletries industries; the Department of the
Environment (DoE) in respect of the effects of various methods of waste disposal
such as carcass burial and incineration; and the Department of Education and
Science (DES), both in handling funds for the Research Councils sponsoring much
of the BSE research, and in giving advice about dissecting bovine eyeballs.

154 Three general features of the arrangement of legislative powers and duties
described in vol. 14: Responsibilities for Human and Animal Health bore directly
on how BSE was handled:

   •   Although Departments in Wales, Scotland and Northern Ireland had
       responsibility for many agricultural and health matters, the guiding principle
       was that issues affecting the safety of food, medicines and other consumer
       products, and the prevention and control of infectious animal and human
       disease, should be dealt with consistently on a UK-wide basis.
   •   The main Acts of Parliament governing the different areas in which BSE
       impacted were a heterogeneous collection of legislation. Each of those
       covering animal health, food safety, wholesomeness of feedstuffs, control of
       pollution, medicines safety, consumer protection, and occupational risk had
       its own set of basic concepts, preferred approach and basic machinery on
       matters requiring public intervention. Associated with each major Act or EU
       instrument was a shoal of subordinate legislation reflecting the differing
       powers, duties, sanctions and enforcing agencies. There could be no uniform
       approach to the response to BSE.
                                                                                         29
FINDINGS AND CONCLUSIONS


            •   Although central government was largely responsible for the Regulations
                made about BSE, it usually fell to local government to enforce them.

         155 Volume 15: Government and Public Administration explains how policy is
         developed and implemented within Departments, the main terminology and
         procedures that crop up throughout the other volumes, the relationship between
         Ministers and officials, and how accountability operates.

         156 The volume also describes conventions for consultation and cooperation
         within and between Departments. The need for ‘joined-up government’ is not new.
         It reflects a basic characteristic of institutions. Policy matters rarely have neat
         boundaries or single solutions. Each Department, division or agency reasonably
         enough has its own agenda, reflecting its particular set of statutory responsibilities.
         It is necessary to secure agreement about the efforts of different agencies with
         different responsibilities, priorities and especially budgets, in order to achieve
         common objectives.

         157 During the 1980s and 1990s decision-making was affected by legislative and
         financial control pressures, and by administrative developments:

            •   the existing legislation. Departments generally had to make do with existing
                primary legislation, although it was often not ideally suited to addressing the
                problems of BSE. New secondary legislation could be introduced, but this
                required clearance, consultation, and time to introduce;
            •   resource planning. Money to run Departments and finance their operations
                had to be voted by Parliament under itemised heads. The justification for
                bids was rigorously scrutinised by the Treasury as part of the control of
                government spending. Voted money could not be switched at will to
                different purposes, nor could Departments overspend. This system involved
                an annual cycle of bids and negotiations for resources for the next three
                years. The cost of any proposed new action was therefore a major
                consideration;
            •   cuts in resources. The heavy squeeze on public spending on administration
                year on year throughout the period, both in Whitehall Departments and in
                local government, required MAFF to make significant cuts in running costs;
                it reduced its staff numbers by 12 per cent between 1986 and 1996. Research
                budgets were being slashed. Making room for BSE work involved
                jettisoning something else. Strict staff ceilings were in operation. Unclear
                prospects made recruitment for many types of post difficult, and staff in post
                were overloaded;
            •   value for money and charging. There was increased emphasis on business
                efficiency, charging for services or certificates, and measured performance
                targets. Setting up Executive Agencies took considerable management time,
                including that involved in setting up systems for charges and fees; and
            •   deregulation. A key aim of the Government was to lift the burden of state
                regulation from industry, especially small businesses. Instructions and
                government papers were issued urging this on Departments. Proposals for
                new measures had to be tested against their cost to industry. Enforcement
                was expected to be done with a light touch.
30
                                                                          SETTING THE CONTEXT


Handling risk

158 In a primitive society, the major hazards are those posed by nature. In a
complex modern society the acts of individuals or corporate bodies may also
involve serious hazards to other members of society. All governments intervene in
many different ways to reduce the exposure of their citizens to hazards created by
nature or by human acts. Dealing with such hazards is one of the most important
functions of government.

159 Every action taken to reduce exposure to hazard has its price. Many
administrative actions taken for this purpose involve government expenditure, to be
recovered in one way or another from the citizen. Statutory measures which prohibit
or regulate potentially hazardous activities impose costs on those to whom the
measures apply and may stifle innovation. Where the activities are commercial,
these costs are likely to be passed on to the customer or consumer. Restriction of
freedom of choice for the individual will usually be part of the cost of a safety
restriction – sometimes the most significant part.

Risk evaluation

160 When considering whether to impose a safety measure the Government has to
balance the benefits that will be achieved from reducing or eliminating exposure to
a hazard against the costs that the measure will involve. This process involves what
is sometimes described as ‘risk evaluation’.

161 A risk is not the same as a hazard. A hazard is an intrinsic propensity to cause
harm. Natural phenomena, physical substances, human activities will be hazardous
if they have an intrinsic propensity to cause harm. A risk is the likelihood that a
hazard will result in harm. A risk can usually be evaluated once the nature of the
hazard and the degree of exposure to it are identified. Risk evaluation involves
considering both the likelihood that a hazard will cause harm and the severity of the
harm that is threatened.

Risk management

162 Action to reduce or eliminate a risk may involve destruction of a substance or
prohibition or regulation of an activity that gives rise to a hazard. Alternatively it
may involve eliminating or reducing the exposure to the hazard. Risk management
involves identifying the options for reducing or eliminating the risk and their likely
efficacy, estimating the costs involved in each option, deciding which, if any, of the
available options to exercise, implementing the chosen options and monitoring the
results.

163 In some circumstances past experience enables the statistician or the
epidemiologist to calculate with some precision the effect that an option will have
on reducing risk. Management of the risks associated with road traffic is such an
example. It is often possible to calculate the number of lives that a particular road
safety measure is likely to save. In such circumstances one can decide on principles
or guidelines that will govern risk management, such as the maximum expenditure
that can be justified per life saved.
                                                                                         31
FINDINGS AND CONCLUSIONS


         BSE and risk

         164 BSE was not like that. Attempts could be made to evaluate the risk to cattle.
         So far as other animals, and humans, were concerned, however, nobody knew
         whether BSE was a hazard or not. In such a situation the Government has to decide
         what precautionary measures to adopt against the possibility that the risk exists. One
         technique that can be adopted is known by the acronym ALARP. This calls for
         weighing the efficacy that any particular measure will have in reducing the notional
         risk against the cost and other consequences of introducing the measure. The aim is
         to reduce the possible risk so that it is As Low As Reasonably Practicable. It
         involves an exercise in proportionality that often calls for nice judgement.




32
3. The early years, 1986–88
165 This is the first of a number of chapters which tell, in summary form, the story
detailed in Volumes 3 to 9 and 11.



Identification of a new disease in cattle

166 The epidemic of BSE may have started with a single diseased cow. Why
should that cow have developed BSE? It is possible that the disease developed
spontaneously as a consequence of a genetic mutation. It is possible (though we
believe less likely) that a mutant strain of the scrapie agent transmitted to one or
more cows. There are other possibilities. No one will ever know.

167 When was the first case? The epidemiologists, with their skills in back
calculation, suggest in the 1970s. Where was it? Again no one can say, though
epidemiologists would point to the early concentration of cases in the West Country
as suggesting that BSE may well have come from there.

168 Did the first case get ill on the farm and end up in the knacker’s yard, or was
it sent to be slaughtered for human food – perhaps before the signs of the disease
were even showing? We cannot know. What we can deduce is that, by one route or
another, the animal’s head, together with other unwanted offal, was sent to the
renderers. The parts carrying the BSE infection contaminated the batch of meat and
bone meal (MBM) produced from the rendering. That MBM was sold to a food
compounder and mixed into cattle feed, contaminating that feed. That feed may
have infected many cows and some of these, by a similar series of events, infected
many more. Thus, like a chain letter, the spread of the disease was almost
exponential.

169 The disease spread wide, and it spread at first unnoticed. It spread wide
because MBM may travel long distances from renderers to the feedmill and the
cattle feed produced by the mill may be widely distributed. The calves which eat the
feed may end their lives far from the farms on which they were born.

170 It spread at first unnoticed because most infected cattle were slaughtered
before showing clinical signs of the disease. When clinical signs did appear, they
were similar to those of some other diseases of cattle. Only histopathology of the
brain could reveal the existence of the new disease. Before that could happen the
carcass had to be sent by a vet to one of the regional State Veterinary Investigation
Centres (VICs), and from there the brain had to be sent to the Pathology Department
of MAFF’s Central Veterinary Laboratory (CVL) at Weybridge. Most cattle
infected with BSE went for slaughter before the clinical signs developed
(‘subclinical cases’). Where a single cow fell ill, the farmer was unlikely to want a
post-mortem examination and, for some reason, not yet clear, BSE tended to strike
down single cows in a herd.

171 The first brain from a cow with what we now know as BSE reached the CVL
in September 1985. It came from a herd in Pitsham Farm in Sussex where unusually        33
FINDINGS AND CONCLUSIONS


         a number of cattle had been struck down with symptoms that we now recognise as
         typical of BSE. The CVL pathologist identified the condition of the brain as
         spongiform encephalopathy, but concluded that this, and a kidney condition from
         which the animal had also suffered, was probably caused by toxicity of some
         description.10

         172 At the end of 1986 pathologists at the CVL identified the possibility that cattle
         had developed a spongiform encephalopathy that was transmissible in the same way
         as scrapie was in sheep. This followed the submission of brain samples from a herd
         in Kent and another from near Bristol. Mr Raymond Bradley, head of the Pathology
         Department, remarked in a note to colleagues:

                    If the disease turned out to be bovine scrapie it would have severe
                    repercussions to the export trade and possibly also for humans.

         173 One witness described meeting Mr William Rees, the Chief Veterinary Officer
         (CVO), who had just heard the news, with ‘steam coming out of his ears’.11

         174 The CVL pathologists identified the emergence of a new disease, which they
         considered might be a bovine form of scrapie, as soon as could reasonably have
         been expected. They are to be congratulated – particularly Mr Gerald Wells and
         Dr Martin Jeffrey, who carried out the initial histopathology.



         Restraints on information

         175 CVL staff thought that they might have identified a bovine form of scrapie,
         but they were not sure. The experts in this field were the members of the
         Neuropathogenesis Unit (NPU) in Edinburgh. If the CVL had consulted them at this
         stage, the NPU would have confirmed that there were very strong indications that
         this was indeed a new Transmissible Spongiform Encephalopathy (TSE). In the
         event the CVL did not seek the collaboration of the NPU until June 1987, and Mr
         Wells did not get confirmation from the NPU of his diagnosis until the end of July.
         Having regard to the importance of this matter, we think that Dr William Watson,
         the Director of the CVL, should have sought the assistance of the NPU from the
         outset.

         176 It was important that MAFF should discover not merely the nature of the
         problem, but also its scale. If private vets and members of the VI (Veterinary
         Investigation) Service around the country were told of what the CVL had found and
         asked to look out for cattle with similar signs, reporting of cases, which might
         otherwise go unremarked, would be encouraged. Unfortunately, in the first half of
         1987 there was a policy that one Senior Veterinary Investigation Officer described
         as ‘a total suppression of all information on the subject’. This was encouraged by
         an understandable anxiety on the part of Mr Wells that MAFF should not go public
         until the CVL was sufficiently sure of its ground to advance a scientifically
         responsible claim to have discovered a new disease. In March 1987 a proposed
         publication about BSE in Vision, a VI Service newsletter, did not proceed. The


         10
              Vol. 3, paras 1.7–1.33
34       11
              Vol. 3, paras 1.34–1.40
                                                                       THE EARLY YEARS, 1986–88


decision was Dr Watson’s, who should not have permitted Mr Wells’s concern to
prevail over the desirability of effective surveillance.

177 Events after March 1987 demonstrated a policy of restricting dissemination of
information about BSE. The principal reason for this was concern about ‘the
possible effect on exports and the political implications’ should news get out that a
possible TSE in cattle had been discovered in Britain. Publication to the VI Service
of information about BSE eventually took place in June. This was not in Vision,
which was circulated to Veterinary Investigation Officers (VIOs) not only in
England and Wales, but also in Scotland. Instead a circular letter was sent to Senior
VIOs in England and Wales, describing the clinical signs and the pathology and
calling for notification of similar cases to a Senior Veterinary Officer at the State
Veterinary Service headquarters at Tolworth, Surrey. It directed that VI staff should
not consult Research Institutes or University Departments, or publish anything
about BSE or discuss it at meetings without clearance. A proposed letter by a VIO
to the Veterinary Record describing the clinical signs and the pathology of BSE was
refused permission for submission to the journal.

178 Primary responsibility for this policy lay with Mr Rees, the CVO, but it
received support from his subordinates, Dr Watson and Dr Bernard Williams, the
head of the VI Service. We can see why there were concerns that reports of a
possible TSE in cattle might harm the industry and, in particular, the export market.
But this did not justify suppression of information needed if disease surveillance
was to operate effectively. Dr Watson and Dr Williams should have urged the merits
of publication and Mr Rees should have permitted it.

179 An article by Mr Wells for the Veterinary Record, which compared the
pathology of BSE and scrapie, was embargoed and it was made plain that
comparisons with scrapie were not acceptable. This line was taken at the instigation
of Mr Rees. He should have permitted publication of the article and he should have
permitted comparisons with scrapie.

180 Had there been a policy of openness rather than secrecy, this would have
resulted in a higher rate of referral of cases to MAFF in the earlier part of 1987. This,
in turn, might have led to a better appreciation of the growing scale of the problem
and hence to remedial measures being taken sooner than they were.

181 In the second half of 1987, restraints on publication of information about BSE
were progressively relaxed. Articles about BSE were submitted to the Veterinary
Record and the disease was the subject of discussion at a number of agricultural
trade meetings. In October articles about the disease appeared in the farming and
national press. The number of cases reported increased rapidly. At the end of May
there had been 6 identified cases and 13 suspected cases. By the beginning of
September there were 66 suspect cases, of which 8 were histopathologically
confirmed. By the end of October the figures were 120 and 29, and by the end of the
year 370 suspects, of which 132 were confirmed.




                                                                                            35
FINDINGS AND CONCLUSIONS


         What was the cause of BSE?

         182 The CVL had only one qualified epidemiologist in 1987, Mr John Wilesmith,
         who headed a small Epidemiology Department. He knew nothing of BSE until late
         in May, when he was asked by Dr Watson to investigate its epidemiology. There
         were then 6 confirmed cases on 4 farms, but as we have seen the numbers were
         about to escalate.

         183 Mr Wilesmith prepared a questionnaire, rolled up his sleeves and set
         off in person to visit farms on which BSE suspects had been reported. Soon
         Mr M Cranwell had to be seconded from Starcross VIC in Exeter to assist him. By
         this time, unknown to Mr Wilesmith, thousands of cattle had been infected by
         recycling of earlier cases and were incubating the disease. Mr Wilesmith assumed,
         quite naturally, that each new case was an index case (that is, arising as a fresh
         incident) and that there was some common factor causing all of them. The search
         was on for that common factor. Vaccines, hormones and organophosphates were
         considered but ruled out: the disease had been found in cattle exposed to none of
         these.

         184 From the outset feed was a runner. In August Mr Wilesmith noted that lamb
         MBM was used in commercial dairy rations, but added that it was not a recent
         introduction. This was a major conundrum. If feed was the cause, what novel
         ingredient or feature had suddenly started to make the feed infective?

         185 Mr Wilesmith carried out calculations which indicated that the exposure of the
         cattle population to the BSE agent was likely to have begun in the winter of
         1981–82. Had anything occurred at about this time to explain the disease?

         186 Further investigations were put in hand to explore, with the help of the feed
         and rendering industries, why it might be that cattle feed had suddenly started
         infecting cattle. By the end of April 1988 Mr Wilesmith had reached no conclusion
         on this. He had, however, concluded that feed was the source of infection and that
         the source of infection in the feed was MBM made from sheep affected by scrapie.
         He set out these conclusions in a report, recommending a temporary ban on the
         inclusion of MBM in cattle and sheep feedstuffs, while further enquiries were made.

         187 Mr Wilesmith and his colleagues are to be congratulated on the rapid
         identification of cattle feed as the cause of the cases of BSE that were being
         reported, and on the advice of a ban on feeding MBM to cattle and sheep. As we
         shall see, this advice was promptly implemented and cut off most of the source of
         infection, turning an escalating disease into one that would peak and decline.

         188 Mr Wilesmith had, however, made some tentative conclusions which were to
         prove erroneous. He concluded that the cases being reported were all index cases.
         He concluded that the common source of infection was scrapie-infected feed which
         would result in the incidence of BSE rising sharply over a short period of time
         before maintaining a constant incidence. In a paper published at the end of 1988 he
         identified a number of factors which might explain why cattle feed had become
         infective around 1981–82. These included an increase in the amount of scrapie-
         infected sheep going for rendering and changes in the rendering process which had
         reduced the temperature applied. In the following year he refined these ideas and
36
                                                                      THE EARLY YEARS, 1986–88


decided that particular significance attached to one specific change in the rendering
process. The use of solvent to extract tallow had been widely abandoned at just
about the right time to explain the outbreak of the disease. This process might well
have played an essential role in inactivating the scrapie agent. When Mr Wilesmith
learned of this change he commented that it was ‘too good to be true’. In that, he
was correct.

189 Mr Wilesmith’s tentative conclusions were reasonable on the data available to
him at the time, but they were wide of the mark, as he was in due course to
acknowledge. The cause of infection of the cases being reported was not the scrapie
agent in the feed, but the BSE agent itself. The cases were not first generation cases,
but the consequence of recycling of BSE. Far from the incidence of BSE infection
being likely to prove constant, it had been escalating year on year and was, in 1988,
infecting cattle at a rate that probably exceeded 10,000 cases a month.

190 Changes in rendering processes may have had some effect on inactivation of
the BSE agent, but they were not decisive or even significant.

191 Mr Wilesmith’s tentative conclusions were widely accepted. They led to
misconceptions, some of which have survived to the present day. We will deal with
them shortly. They receive detailed consideration in Volumes 2 and 3.

The scrapie theory

192 The conclusion that BSE had been transmitted from scrapie-infected sheep
was generally accepted. It was a reassuring conclusion. Sheep affected by scrapie
had been eaten by humans for 200 years or more, without apparent ill effect. It was
likely that scrapie in cattle would prove similarly innocuous. Although, as the years
passed, evidence mounted that discredited the scrapie theory, this was never made
clear to the public and most people are still under the impression that cattle caught
BSE from scrapie-infected feed.

193 The conclusion that rendering changes had permitted the BSE agent to survive
unscathed, whereas previously it had been inactivated, is also still widely accepted.
There are two variations on this theme:

          i.    Some accuse the Government of having recklessly relaxed the
                Regulations governing rendering, or of having failed to impose a
                sufficiently rigorous regulatory regime.
          ii.   Some accuse the rendering industry of having put the safety of their
                product at risk by cutting corners in order to cut costs.

194 Neither of these accusations is valid. There was no relaxation by the
Government of rendering standards. Up to 1981 the rendering industry was largely
unregulated. In 1981 Regulations were introduced that set minimum standards for
the product of renderers, to be checked by regular sampling. The Regulations were
strengthened in 1989.12 A more complex alternative involving the licensing of
rendering plants was not pursued, but this would not have addressed the problem of
BSE and the proposed criteria for the grant of licences would not have prevented it.
That problem was not foreseen, nor was it reasonably foreseeable.
12
     See Volumes 13 and 14                                                                37
FINDINGS AND CONCLUSIONS


         195 By the same token the changes made by the rendering industry to their
         processes did not, overall, make them more vulnerable to BSE. Neither the old nor
         the new processes would have inactivated the BSE agent. No rendering process has
         yet been devised which can guarantee to do so, though infectivity is reduced.

         196 The theory that the rate of infection would have reached a plateau led to the
         conclusion in 1989 that the scale of the problem could be related to the rate at which
         cases were being reported. The Southwood Working Party on Bovine Spongiform
         Encephalopathy reported that year on the basis that the effect of recycling could be
         ‘minimal and undetectable’, in which case 350 to 400 cases a month could be
         expected. In early 1993 cases were being reported at a rate of around 1,000 a week.13

         197 These misconceptions involve no criticism of Mr Wilesmith. They
         demonstrate that in 1987 and 1988 lack of data made it impossible to appreciate
         the nature and extent of the disaster that had already occurred.



         The ruminant feed ban

         198 While Mr Wilesmith was exploring why cattle were succumbing to BSE,
         consideration was also being given to the implications that the disease might have
         for humans. Before turning to that part of the story, let us follow the reaction to
         Mr Wilesmith’s advice that the practice of including animal protein in cattle feed
         should be subjected to a temporary ban.

         199 If Mr Wilesmith’s conclusions were tentative, Mr Rees, the CVO, thought that
         the picture was clear. In a submission to Mr John MacGregor, the Minister of
         Agriculture, Fisheries and Food, he advised that he was:

                   . . . satisfied from the information produced by the investigating teams that
                   the source of the transmissible agent which has caused BSE is through meat
                   and bone meal derived from sheep material in which the rendering process
                   has failed to inactivate the scrapie agent. Affected sheep material is
                   continuing to be processed and it must be assumed therefore that cattle
                   continue to be exposed to infection.14

         200 He advised that the feed industry should be asked to agree a voluntary
         withdrawal of MBM from ruminant feed, but that if they refused, a mandatory ban
         should be imposed.

         201 Mr MacGregor was even more decisive. On 19 May 1988 he determined that
         there should be a ‘speedy and compulsory ban on sheep meat material in feed for
         ruminants’. It fell to Mr Alan Lawrence, a Grade 7 official in MAFF’s Animal
         Health Division, to implement this decision in consultation with departmental
         lawyers and with the benefit of advice from his administrative and veterinary
         colleagues. It was decided that the ban should extend to the feeding of ruminant
         protein to ruminants. In effect the ban was subsequently operated as if it
         encompassed all animal protein, for no renderers attempted to segregate their raw
         materials in order to produce non-ruminant MBM. The ban was achieved by an
         13
              See vol. 4: The Southwood Working Party, 1988–89
38       14
              YB88/5.6/11.3
                                                                              THE EARLY YEARS, 1986–88


Order15 signed by Mr MacGregor and Welsh and Scottish Office Ministers on
10–14 June. This made it an offence to sell, supply or use for feeding to ruminating
animals any feedstuff in which the offender ‘knew or had reason to suspect’ that any
animal protein had been incorporated. The ban was initially only up to the end of
1988, but it was subsequently to be extended, and finally made permanent.

202 This simple Order has been described by one distinguished epidemiologist as:

           A spectacularly successful control measure . . . one of the notable success
           stories of global disease control.

203 It has, today, come close to eradicating an epidemic that, at its height, was
of gigantic proportions. Primary credit for this goes to Mr Wilesmith and his
Department for their diagnosis of the source of infection, but credit also is due to
Mr Rees and Mr MacGregor for their prompt and decisive response. Unhappily,
though, the measure was not a total success. There were shortcomings in its
implementation. We turn to consider why this was.

204 The question arose in the course of consultation as to when the ban should
come into effect. After consulting its members, the UK Agricultural Supply Trade
Association (UKASTA) asked for a three-month period of grace to enable the
industry to clear from the distribution channels all stocks of ruminant feed that had
already been compounded. After taking advice from the veterinarians in MAFF, Mr
Lawrence proposed a two-month period of grace. MAFF’s press office advised that
a delay as long as this would lead to accusations of risking the further spread of the
disease simply to make life easy for the industry. Mr MacGregor, on the advice of
Mr Alistair Cruickshank,16 compromised and decided that the ban should come into
effect on 18 July – five weeks from the date of the Order.

205 We initially questioned the grant of this period of grace, but concluded that
our reservations were the result of being wise after the event. Mr Kevin Taylor, one
of the MAFF veterinarians involved in the preparation of the ruminant feed ban,
explained to us his reasons for viewing a period of grace of as long as two months
as perfectly acceptable from a veterinary point of view. On the basis of the
information then available it did not seem to him that such a delay was going to
make very much difference. The industry had been exposed to infected feed for
380 weeks. A few weeks more would not make a great deal of difference.

206 In June 1988 MAFF officials reasonably expected, on the basis of
Mr Wilesmith’s advice, that the rate of infection was likely to have stabilised at
about 60 cases a month. Mr Taylor considered that if no period of grace had been
granted, farmers and the industry would initially have disregarded the ban. We
found force in these points and reached the conclusion that the compromise period
of grace decided upon by Mr MacGregor could not be criticised. Had it been
appreciated that cattle were being infected at the rate of thousands of cases a week,
we have no doubt that a very different approach would have been adopted.

207 Much later it became apparent that infected feed had continued to be fed to
cattle on a substantial scale after 18 July. Nearly 12,000 cattle born after the ban
(BABs) in 1988 and over 12,000 born in 1989 subsequently developed clinical signs
15
     The Bovine Spongiform Encephalopathy Order 1988
16
     MAFF Under Secretary (Grade 3) responsible for the Animal Health Group                      39
FINDINGS AND CONCLUSIONS


         of BSE. A far larger number must have been infected, but slaughtered before signs
         became apparent. Some of these cases will have resulted from accidental
         contamination of feed. Some will have resulted from farmers, who had little or no
         means of knowing whether their feed contained ruminant protein, continuing to use
         the feed they had in stock. But we are satisfied that some feedmills and feed
         merchants deliberately continued to sell cattle feed containing animal protein after
         the ban come into effect.

         208 Had the only source of contaminated feed been existing stocks of cattle feed
         made up before the ban came into effect, the BABs would have come to an end once
         this had been consumed. In the event, over 5,600 cattle born in 1990, 4,500 born in
         1991, 3,000 born in 1992, 2,200 born in 1993 and 1,000 born in 1994 were to go
         down with the disease. With hindsight, it is clear that most of these infections
         resulted from cross-contamination of cattle feed with pig and poultry feed,
         containing infective MBM, in the feedmills. The risk, indeed the certainty, of a
         degree of cross-contamination when the same production lines are used to produce
         different batches of feed is, and was in 1988, well established. One reason that has
         enabled us to conclude that cross-contamination did indeed result in infection of
         cattle is knowledge that we now have as to the quantity of infectious material that
         suffices to transmit BSE orally in cattle.

         209 An experiment carried out by the NPU has demonstrated that ½ gram of
         homogenised brain from BSE-infected cattle is sufficient to transmit the disease
         orally across the species barrier to sheep and goats. Another experiment carried out
         by the CVL has demonstrated that 1 gram of such material can transmit the disease
         orally to cattle.17

         210 The results of these experiments were not available when the ruminant feed
         ban was introduced. What consideration was given at that stage to the amount of
         material that might infect? What consideration was given to the question of whether
         cross-contamination might pose a risk of infection? UKASTA witnesses spoke of
         receiving repeated reassurances from MAFF right up to 1994 that a large amount of
         contaminated feed would be necessary to infect a cow.

         211 We found no specific evidence of when or by whom such assurances were
         given. A number of MAFF administrators spoke of their understanding that a large
         amount of infective material was needed to infect. Some of the professionals –
         Dr Watson, Mr Kevin Taylor, Mr Bradley – told us that they had no idea what the
         minimum quantity would be. There was general surprise, when the result of the
         attack rate experiment was made known, that as little as 1 gram had sufficed to
         infect. Although there is no record of Mr Keith Meldrum18 reassuring UKASTA
         that there was no need to worry about cross-contamination, he is recorded as telling
         representatives of the cattle industry in June 1988 that feedmills presented at worst
         a low contamination risk and would not be investigated. He advised at the same
         meeting that MBM could safely be used as fertiliser because the dose that might be
         received by grazing cattle would almost certainly be too low to cause disease.

         212 Was there any valid basis upon which Mr Meldrum could have concluded in
         1988 that cross-contamination in the feedmill would not involve sufficient
         quantities of infective material to give rise to transmission? We have concluded that
         17
              See vol. 2: Science
40       18
              Mr Meldrum succeeded Mr Rees as Chief Veterinary Officer in June 1988
                                                                                       THE EARLY YEARS, 1986–88


there was not. Mr Wilesmith told us that he had concluded that a very small amount
of infective material would suffice to infect. This he deduced from the small
inclusion rate of MBM in calf rations. He believed that his view should have been
widely shared by administrators at MAFF. Those who designed the experiments at
the NPU and CVL, to which we have referred above, envisaged the possibility that
½ or 1 gram would suffice to infect. Had the question of the amount of material
needed to infect been explored at the time of the imposition of the ruminant feed ban
with those best placed to advise, the conclusion should have been reached that this
amount might be very small.

213 Mr Meldrum told us that if he or any other MAFF or industry representative
had known at the time that the infective dose was so low as to lead to cross-
contamination problems, the issue would have been pursued. As it was, the
existence of a danger from cross-contamination was not considered to exist at
the time.

214 We have concluded that at the time that the ruminant feed ban was imposed,
there was a lack of rigorous thought about its implementation. One person who
should have given more thought to this was Mr Meldrum. He had knowledge of how
feedmills operated, and of the problem of cross-contamination between batches. He
assumed this would not matter but did not have adequate grounds for that
assumption. A failure to attach significance to the possibility of infection through
cross-contamination in feed was understandable when the apparent rate of infection
was only about 60 cases a month. However, in the course of September 1988,
435 cases of BSE were reported in Great Britain. Once this was apparent,
Mr Meldrum should have ensured that proper consideration was given to this
matter. This should have led to guidance being given to both the feedmills and to
those farmers who mixed their own feed, on the need to take precautions to
minimise cross-contamination.19

215 Mr Meldrum is a man of great energy and industry. He had only just taken up
the reins of the CVO. His national and international duties were onerous. These are
considerations which should temper any criticism of his oversight on this occasion.

216 Failure to appreciate that cross-contamination mattered carried with it a failure
to appreciate the importance of a test that would detect cross-contamination. When
the ruminant feed ban was introduced, there was no test which would detect animal
protein in compound feed, let alone ruminant protein. Without such a test the Order
was unenforceable. Steps were put in hand to develop, in-house, the ELISA
technique so as to produce a test that would identify ruminant protein in feed. This
was not treated as a matter of priority. Deliberate breach of the ban was not
considered likely and accidental cross-contamination was not considered to be
cause for concern. Development of the ELISA test followed a leisurely course and
did not approach achievement until the end of the period with which our Inquiry is
concerned.20

Exports

217 The United Kingdom exported very little compound feed, but did export
significant quantities of MBM. This was exported initially to Europe to
19
     For detailed discussion see vol. 3: The Early Years, 1986–88, paras 4.117–4.171
20
     See further: vol. 2: Science and vol. 5: Animal Health, 1989–96                                      41
FINDINGS AND CONCLUSIONS


         manufacturers of concentrates who re-exported their products to the Middle East or
         North Africa. Some have suggested that the United Kingdom should have imposed
         a ban on the export of MBM when the ruminant feed ban was introduced to try to
         make sure that foreign countries did not infect their cattle with BSE. This would
         have been difficult. Renderers were still permitted to sell MBM to British
         purchasers for incorporation in pig and poultry feed. Most MBM that was exported
         was used for the same purpose. An attempt to prohibit exports would have been
         likely to be challenged in the Courts. It could be argued convincingly that foreign
         importers could be adequately protected by warnings that MBM should not be fed
         to cattle.

         218 Were adequate warnings given? Mr John Gummer urged before the ruminant
         feed ban was introduced, when he was the junior Agriculture Minister, that we had
         a moral duty to warn our neighbours of the danger of feeding MBM to cattle. Under
         European law this country was obliged to give notice of the ruminant feed ban to all
         EU members and did so. What of the countries that were not members of the EU?
         Mr Meldrum told us that he relied on the customary means of communicating with
         them on the subject of animal diseases. He notified the Office International des
         Epizooties, which passed the information on to all members in a report of its annual
         General Session in May 1989. In February 1990 Mr Gummer, by now the Minister
         of Agriculture, Fisheries and Food, insisted that Mr Meldrum take the further step
         of writing a letter of warning to Chief Veterinary Officers of all countries which
         imported MBM from the UK. There is scope for arguing that Mr Meldrum should
         have done this earlier. We think the argument is academic. The only country outside
         the EU where it is suspected that cattle were infected with BSE as a result of
         importing MBM is Switzerland, and it seems that the MBM in question reached
         Switzerland via Belgium. If this occurred after the ruminant feed ban, both Belgium
         and Switzerland were aware that ruminant protein was suspected to be the cause of
         BSE. Accordingly we have seen no need to pursue this issue further.



         Human health implications

         219 BSE had implications for human health in many different ways. The one of
         which the public was most aware was the possibility that BSE posed a risk through
         food. Responsibility for addressing this risk was shared by MAFF and the
         Department of Health (DH). Mr Meldrum emphasised to us that DH was
         responsible for assessing risk to human health. He told us that he did his best to
         avoid making public comments on this matter. He saw MAFF’s role as being risk
         management, together with the provision of advice to DH on matters that fell within
         the expertise of the veterinarians.

         220 We have not found it easy to draw a distinction between risk evaluation and
         risk management. Throughout the BSE story, MAFF officials and Ministers appear
         to us to have proceeded on the footing that it was their responsibility to see that
         whatever left the slaughterhouse to go into the human food chain was safe to eat.
         MAFF made the running in considering both what was and what was not safe to go
         into the food chain, and how what was not safe should be kept out of it. Problems
         arising over the safety of animal feed, which were unquestionably MAFF’s
         responsibility, tended to mirror problems of the safety of human food. In relation to
42       the latter, DH was consulted, but not often actively involved in the initial
                                                                                                 THE EARLY YEARS, 1986–88


formulation of policy. Whether DH should have been more involved is a matter that
we shall consider.

221 BSE also posed a potential risk to human health as a result of the use of bovine
products or by-products in the making of pharmaceuticals and cosmetics. So far as
the former were concerned, DH had responsibility for human medicines and MAFF
for veterinary medicines. Responsibility for the safety of cosmetics fell to the
Department of Trade and Industry (DTI). These areas, and the occupational risks
posed by BSE to those who handled cattle, or their products, we consider in separate
chapters of this volume.

222 MAFF Ministers were first informed about BSE after the General Election in
June 1987. Mr MacGregor was appointed Minister of Agriculture, Fisheries and
Food, and Mr Gummer his Minister of State. Mr Donald Thompson retained his
post as MAFF Parliamentary Secretary. In a note to him about the disease, Mr Rees
commented, ‘There is no evidence that the bovine disease is transmissible to
humans,’ a statement that was to be frequently repeated. Mr Thompson met officials
on 22 July. The Permanent Secretary, Sir Michael Franklin, observed that the
establishment of any risk to human health was the highest priority, and Mr
Thompson said that he was particularly concerned about this. In a paper for him,
which was subsequently seen by the Minister, Dr Watson advised that there was no
reason at all to believe that any risk to human health existed.

223 By the end of July, 46 probable cases of BSE had been identified involving
18 herds. Both Mr Thompson and Sir Michael Franklin had raised concerns about
human health. Mr Rees did not share those concerns. He viewed BSE as an animal
health not a human health problem. Dr Watson thought it very unlikely that BSE
posed a risk to human health.

224 In mid-September Mr Rees prepared a progress report for Ministers. This
included a statement that DHSS was aware of the problem.21 Dr Watson had told
Mr Rees that Dr Thomas Little, the Deputy Director of the CVL with responsibility
for veterinary medicines, had discussed BSE with DH colleagues at a meeting of a
subcommittee of the Committee on Safety of Medicines. Regrettably Mr Rees did
not explain to Ministers the limited nature of the communication that had occurred.
There had been an informal discussion in the margins of that meeting, but news of
BSE had gone no further within DH.

225 By this time there were 73 suspected cases in 36 herds across 11 counties. In
a Q&A briefing for the media in October, Mr John Suich, who headed the Animal
Health Division, included the following:

           Q : Can it be transmitted to humans?

           A : There is no evidence that it is transmissible to humans.

226 On 11 November 1987 he repeated this comment in a briefing for
Mr Thompson, adding the suggestion that reassurance could be drawn from an
analogy with scrapie.


21
     The Department of Health and Social Security (DHSS) split into two separate Departments – DH and DSS – during 1988   43
FINDINGS AND CONCLUSIONS


         227 On 4 December Lord Montagu of Beaulieu wrote to Mr MacGregor expressing
         concern at the fact that cattle with BSE were being slaughtered for human
         consumption. He suggested that:

                Perhaps this is an area where the Ministry should make the disease notifiable
                and pay compensation at the full value for animals infected.

         228 It seems that this letter served as a catalyst for formal consideration by MAFF
         officials of whether action should be taken to address the possibility that BSE might
         be transmissible to humans, though other letters from the public were received to
         similar effect. Mr Rees chaired a meeting of MAFF officials on 15 December. It was
         agreed that a paper should be prepared for Ministers setting out the options. On
         29 December an article in The Times, headed ‘Mystery Disease Strikes at Cattle’,
         observed that there was no indication of whether the disease was transmissible to
         humans. By the end of the year, 370 suspect cases had been reported and 132 had
         been confirmed.

         229 The options to be submitted to Ministers were discussed by, among others,
         Mr Rees, Mr Cruickshank, Dr Watson, Mr Meldrum, Mr Wilesmith and
         Mr Lawrence. The submission was perfected by 16 February 1988 and forwarded
         by Mr Cruickshank to Mr Edward Smith, the Deputy Secretary at MAFF. In his
         covering minute, Mr Cruickshank remarked:

                We do not know where this disease came from, we do not know how it is
                spread and we do not know whether it can be passed to humans. The last
                point seems to me the most worrying aspect of the problem. There is no
                evidence that people can be infected but we cannot say there is no risk.

         This was an acute analysis of the position so far as humans were concerned.
         Mr Cruickshank’s analysis of this aspect of BSE was not to be bettered, or even
         significantly augmented, by the scientists who were to consider the problem in the
         months to come.

         230 The submission itself observed that it was uncertain whether the disease was
         transmissible to humans, and continued:

                We could therefore be criticised for allowing affected animals to be sold for
                human consumption. MAFF are already being asked to advise on whether
                there is any risk to humans.

         231 The option recommended was a policy of slaughter of affected animals with
         payment of compensation, the principal advantage of which was to enable the
         Government to answer criticism about human health implications. The submission
         took some pains to emphasise that payment of compensation was appropriate as the
         measure would be taken mainly for public health reasons, not in order to eradicate
         the disease.

         232 Mr Smith forwarded the submission to the Permanent Secretary, now
         Mr Derek Andrews, adding that as the policy was in the interests of public health,
         it would not be appropriate to look to the industry to fund it.

44
                                                                     THE EARLY YEARS, 1986–88


233 It is remarkable that MAFF officials had prepared this submission, whose
recommendation was based essentially on an evaluation of risk to human health,
without involving anyone at DH. The expressions of concern in the summer of 1987
by Sir Michael Franklin and Mr Thompson, coupled with the growth of the
epidemic, called for joint consideration by MAFF and DH, with assistance from
experts in TSEs, as to whether BSE might be transmissible to humans. Had this
course been followed, we have little doubt that a joint submission would have been
made to both MAFF and DH Ministers to the same effect as that which went
forward to Mr MacGregor, but backed by conclusions as to the uncertainty about
risk to humans that would have carried more weight than those of MAFF officials
alone. It might moreover, as we shall see, have brought together those licensing
veterinary and human medicines to consider their shared problems.

234 We sought explanations for the failure to involve DH from Dr Watson,
Mr Cruickshank and Mr Rees. We have summarised their explanations in
Volume 3.22 We find that the true reasons were (i) a belief on the part of some
that BSE was an animal and not a human health problem and (ii) a degree of
interdepartmental reserve which led Dr Watson, Mr Rees and Mr Cruickshank to
conclude that BSE was their problem to be resolved without the need for outside
assistance – or interference – from DH. In this, each of them was at fault. The
consequence, as we shall show, was a lengthy delay in reaching a decision as to the
precautionary action to be taken.

Mr MacGregor’s reaction

235 Mr MacGregor’s previous office had been Chief Secretary to the Treasury.
We believe that MAFF officials anticipated that he would have reservations about
a policy that involved paying compensation out of public funds to farmers for the
slaughter of sick animals. In this they were correct. Mr MacGregor’s initial reaction
to the submission was to be ‘very cautious’. He expressed concern that if
compensation were paid for slaughtering cattle with BSE, there would be a ‘read
across’ to situations where the destruction of diseased crops had been ordered
without payment of compensation. Rhizomania, a disease of sugar beet, was an
example.

236 Mr Cruickshank told us that he and his colleagues considered Mr MacGregor’s
reaction to the submission to be a peremptory rejection. Sir Derek Andrews
demurred at this description, and so would we. Mr MacGregor’s initial reaction to
a policy that involved payment of compensation was unfavourable, but he
nonetheless agreed that the advice of the Chief Medical Officer (CMO) should be
sought. His reaction affected, however, the manner in which the CMO, Sir Donald
Acheson, was approached. The intention had been to tell him that MAFF wished to
introduce a slaughter and compensation policy and to ask him to advise whether or
not BSE posed a risk to humans. Had that approach been adopted, we think it likely
that Sir Donald would have endorsed MAFF’s proposed policy. As it was things
took a different turn.

237 It was unfortunate that Mr MacGregor did not share his officials’ view of the
merits of the slaughter and compensation policy. It would not, however, be fair to
criticise him for his reservations, for they did not lead him to reject the policy. His
22
     Vol. 3: The Early Years, 1986–88, paras 5.125ff                                      45
FINDINGS AND CONCLUSIONS


         decision to consult the CMO before reaching a final decision fell well within the
         range of responses that were reasonably open to him.

         Sir Donald Acheson’s advice

         238 Mr Andrews wrote to Sir Donald Acheson on 3 March 1988. He described
         the nature of BSE. This was the first that Sir Donald had heard of the disease.
         Mr Andrews then raised the question of whether BSE might be transmissible to
         humans. He wrote:

                It would be very helpful therefore to have your advice on the view we should
                take of the possible human health implications and how we should handle
                questions about the risks to human health.

         239 This put the ball of recommending what action should be taken into
         Sir Donald’s court, and with no warning at all. Sir Donald’s reaction was to
         call an interdepartmental meeting to consider the matter.

         240 Those present at this meeting were not able to form a firm view as to whether
         or not BSE posed a risk to human health. It was agreed to recommend to Health
         Ministers that a small group of experts be set up to advise on the human health risks
         and possible preventive measures. Sir Donald commented that he thought it highly
         likely that the advice would be that carcasses of affected animals should not go for
         human consumption.

         241 We found this decision disappointing. MAFF officials had formed the view
         that unless one could be confident that they posed no risk to humans, sick animals
         should not be permitted to be slaughtered for food. The Southwood Working Party,
         set up on Sir Donald’s recommendation, was to take the same view immediately it
         met. This was, we feel, no more than common sense. Referring the matter to an
         expert Working Party was bound to result in significant delay. A better and more
         robust response would have been to recommend that the practice of eating diseased
         cattle should cease at once. We have concluded, however, that it would not be fair
         to criticise Sir Donald for the course that he took. He was put in an invidious
         position, being asked for advice without notice on policy that had significant
         consequences. Those whom he summoned to help him decide on what to do
         expressed uncertainty. In these circumstances, we find that the decision to
         recommend that the matter be referred to an expert group fell within the range of
         reasonable responses open to Sir Donald.

         242 Delay did indeed result, however. Over three months were to elapse before the
         Southwood Working Party was constituted and met for the first time. During this
         period MAFF came under increasing pressure to take action. On 22 April 1988 a
         front page article in Farming News accused MAFF of seriously underestimating the
         extent of BSE and referred to disquiet about whether the disease posed a danger to
         humans. By then there had been 421 cases confirmed in 352 herds.

         243 Mr MacGregor continued to set his face against any suggestion that the
         Government should fund a compulsory slaughter and compensation scheme. He
         accepted a recommendation that BSE should be made a notifiable disease – a
         measure designed to give MAFF a better picture of the incidence of the disease and
46
                                                                    THE EARLY YEARS, 1986–88


the power, if necessary, to impose movement controls on animals. BSE was made
notifiable in June 1988 by the same Order that introduced the ruminant feed ban.
The rate of reporting leapt almost overnight from 60 cases a month to 60 cases a
week. The Order required that the heads of all these cases be surrendered to MAFF;
the brains were then removed and examined by the CVL. So far as the proposal for
compulsory slaughter was concerned, discussions were carried on with the farming
industry to explore the possibility of an industry-funded scheme. Industry was told
that there was no question of government funding being provided. Industry’s
response was that it was for the Government to fund compensation if compulsory
slaughter were to be introduced.

244 On 4 June 1988 an article in the British Medical Journal, co-authored by a
doctor and a dietician, pointed out that if BSE were transmissible to humans it might
be years before infected individuals succumbed. The authors wrongly assumed that
animals showing signs of sickness would not enter the food chain, but went on to
say that it was ‘naïve, uninformed and potentially disastrous’ to assume that animals
incubating the disease but not yet showing signs posed no risk to humans.

245 On 20 June the Southwood Working Party met for the first time.23 They were
horrified to learn that animals sick with BSE were being slaughtered for food. The
next day Sir Richard Southwood wrote to Mr Andrews recommending that
carcasses of BSE-affected animals should be condemned and destroyed.
Mr MacGregor’s officials advised him that compulsory slaughter should be
introduced and that the Government would have to pay compensation under the
Animal Health Act 1981 – they recommended that this should be fixed at 50 per cent
of the value of a sound animal. Mr MacGregor wrote to Mr John Major at the
Treasury urging, though with reluctance, that payment of compensation at this level
be approved.

246 At the same time, Sir Donald Acheson informed Mr David Mellor, the Health
Minister, that destruction of the carcasses of clinically affected animals was
essential on the grounds of risk to humans. It was on this basis that the consent of
the Treasury was given to the payment of compensation. Mr MacGregor had
suggested that the cost of this measure would be around £250,000 a year on the basis
that cases would continue to be reported at a rate of about 60 a month. He cannot
yet have been aware of the increase of the reporting rate consequent upon the
notification requirement.

247 The Order providing for compulsory slaughter and destruction of cattle
suffering from BSE came into force on 8 August. Nearly six months had gone by
since MAFF officials had first recommended this course.




23
     See vol. 4: The Southwood Working Party, 1988–89                                   47
     4. The Southwood Working
     Party and other scientific
     advisory committees

     The Southwood Working Party
     248 The Southwood Working Party24 consisted of Sir Richard Southwood,
     Professor of Zoology at Oxford University; Professor Anthony Epstein FRS,25
     a virologist; Professor Sir John Walton,26 a neurologist; and Dr William Martin,
     a veterinarian who had just retired from the Directorship of the Moredun Research
     Institute in Edinburgh. Sir Richard emphasised to us that they were not experts in
     the narrow sense of having particular expertise in TSEs. Each was, however, a
     scientist of the highest standing in his field and together they were well placed to
     consider the available data and to give a considered view as to what implications
     these suggested that BSE might have for human health.

     249 This was precisely the task that Sir Donald Acheson wanted the Working Party
     to perform. When writing to Sir Richard on 8 April 1988, he suggested a first
     meeting of the group as soon as possible, a small number of additional meetings at
     the end of the summer and ‘a very brief note with recommendations’. In the event
     a substantial report was delivered in February 1989. The Working Party’s wide
     terms of reference were:

                To advise on the implications of Bovine Spongiform Encephalopathy and
                matters relating thereto.

     250 The Report addressed both human and animal health. The original reason for
     this had been to ‘play down the human health issue’. Sir Richard had, however, been
     anxious from the outset to have broad terms of reference and he had also been
     determined that the Report should be published. Happily the breadth of the terms of
     reference did not inhibit MAFF officials from recommending, before the Working
     Party had been fully constituted, that a ruminant feed ban should be introduced.

     251 The Working Party were served by a joint secretariat, consisting of Mr Alan
     Lawrence, an official in MAFF’s Animal Health Division who was given special
     responsibility for BSE, and Dr Hilary Pickles, a Principal Medical Officer whom
     Sir Donald Acheson appointed to take the lead in DH in relation to BSE.

     252 Although the Working Party took longer than had been hoped to produce a
     Report, they lost no time in making important interim recommendations. They had
     asked what happened to material from affected animals and been told that these
     animals would usually go to be slaughtered for human food, in the same way as
     healthy animals. They told us that they were horrified by this and felt it was their
     24
          Who are the subject of Volume 4 of this Report
     25
          Now Sir Anthony Epstein
48   26
          Now Lord Walton
          THE SOUTHWOOD WORKING PARTY AND OTHER SCIENTIFIC ADVISORY COMMITTEES


job to stop it happening immediately. In consequence, after their first meeting on
20 June 1988, Sir Richard wrote to Mr Andrews recommending that carcasses of
clinically affected animals be destroyed by incineration or a comparable method.
The removal of the head was not an adequate safeguard as that was not the only
source of infection. This recommendation was accepted and implemented. The
measure proved of crucial importance in protecting humans, and also animals, from
the risk of infection with BSE. The Working Party are to be commended for their
prompt and decisive action.

253 The Working Party made further immediate recommendations: that an expert
working party should be set up to advise on the research in hand and the research
required in relation to BSE; that priority should be given to a study to see whether
BSE transmitted from cow to calf; and that tests be carried out to see whether
scrapie could be transmitted to cattle. This was further wise advice promptly given.
It led to the setting up of the Tyrrell Committee on research.

254 The Working Party were not to meet again until November. In the meantime,
the two secretaries, and Mr Wilesmith, who had been asked to act as expert adviser
to the Working Party, set about drafting sections of the Report.

255 The second meeting of the Southwood Working Party on 10 November 1988
led to interim recommendations that the ruminant feed ban, which was due to expire
at the end of the year, be extended indefinitely, and that milk from cows affected
with BSE be destroyed. Dr Richard Kimberlin, who had retired from being Acting
Director of the Neuropathogenesis Unit (NPU), Edinburgh, to run his own
consultancy in TSEs, attended this meeting. Experiments at the NPU had recently
demonstrated that BSE could be transmitted to mice, and there was discussion about
the likelihood of transmission from cow to calf. There was also discussion about
whether it was safe to eat ox brain. The Working Party decided that it would not be
appropriate to ban the eating of UK ox brain but that it was worth consideration
whether products containing brain should be required to be labelled, leaving the
consumer to make his or her own choice. The Working Party subsequently dropped
the idea of labelling as they were informed that this would involve complications
under European law.

256 It was agreed at the second meeting that those responsible for occupational
health and for the safety of medicines should have their attention drawn to the need
to address potential risks posed by BSE. Again, the Working Party are to be
commended for taking action to safeguard human health in advance of delivering
their Report. We shall consider the response to their action when we come to
consider the topics in question.

257 The Working Party met again on 16 December and had a final meeting on
3 February 1989. The contents of their Report were considered in detail on both
occasions, and we shall now consider these.

Epidemiology

258 The first eight pages of the Report consisted of a history of BSE and an account
of what was known about TSEs. These were largely written by Mr Wilesmith,
Mr Lawrence and Dr Pickles, the latter topic being a summary of a substantial
                                                                                       49
FINDINGS AND CONCLUSIONS


         number of published papers, with which members of the Working Party would have
         made themselves familiar. There then followed a chapter on ‘the cause of BSE:
         the epidemiological evidence’. This had been written by Mr Wilesmith. It set out
         the tentative conclusions that we have detailed in the previous chapter, including
         the following:

            •   the epidemiology was typical of an extended common source epidemic;
            •   all affected animals appeared to be index cases;
            •   the common feature was the use of commercial concentrates in feed;
            •   a possible explanation for the emergence of BSE was a change in the
                exposure of cattle to ovine-derived protein and the scrapie agent due to
                i.    more scrapie-infected material going to be rendered;
                ii.   changes in the rendering processes.

         259 A subsequent chapter, also written by Mr Wilesmith, dealt with ‘the Future
         Course of the Disease’. This stated that the effect of recycling of BSE was
         impossible to quantify and possibly minimal and undetectable, in which case a
         constant incidence of 350–400 cases a month could be expected. The possibility of
         maternal transmission was recognised, but it was observed that this would be
         unlikely to sustain BSE in the national cattle population.

         260 The Working Party did not see it as their role to conduct a critical review of
         Mr Wilesmith’s conclusions. We do not suggest that they should have done. The
         Report did nothing, however, to dispel the impression that the conclusions in
         question had been reached, or endorsed, by the members of the Working Party. In a
         covering letter to Ministers, published with the Report, the Working Party thanked
         Mr Wilesmith and others for their assistance and added, ‘The Report, however,
         remains our own.’ We think that the Working Party should have made it plain that
         the section of the Report dealing with epidemiology had been provided by
         Mr Wilesmith and was based on data which they had not been able to review. In the
         event their Report added weight to a number of epidemiological conclusions which
         subsequently proved to be fallacious, the most significant being that the cases of
         BSE were index cases of cattle infected with scrapie. It was this theory which gave
         so many the false reassurance that it was very unlikely that BSE was transmissible
         to humans.

         Risk to humans

         261 In the most important part of their Report, the Working Party set out their
         views on the possibility that BSE might be transmissible to humans. These were,
         in summary:

            •   Humans were susceptible to spongiform encephalopathies.
            •   Neural and, to a lesser extent, lymphoid tissue carried the infection, while the
                risk was far less with other tissues.
            •   Parenteral inoculation was more efficient in transmitting disease than oral or
                topical exposure.
50
          THE SOUTHWOOD WORKING PARTY AND OTHER SCIENTIFIC ADVISORY COMMITTEES


   •   The greatest risk in theory would be from parenteral injection of material
       derived from bovine brain or lymphoid tissue.
   •   Medicinal products for injection or surgical implantation using bovine
       tissues might be capable of transmitting infectious agents.
   •   Direct inoculation of bovine tissue could arise accidentally in certain
       occupations.
   •   In these and in other circumstances the risk of transmission of BSE to
       humans appeared remote.

262 The Working Party commented that because the risk of transmission of BSE
to humans could not be entirely ruled out, action had been taken to remove known
affected cattle from the human food chain. The Medicines Licensing Authority had
been alerted to potential concern about BSE in medicinal products and would ensure
that scrutiny of source materials and manufacturing processes now took account of
the BSE agent. The Health and Safety Executive had also been alerted to potential
concern about BSE.

263 The Working Party had this to say about possible risks from eating animals
incubating BSE but not yet showing clinical signs:

       It has been suggested, although clinically affected animals are being
       slaughtered and destroyed, that consideration should be given to products
       containing brain and spleen being so labelled, to enable the consumer to
       make an informed choice. The Working Party believes that risks as at present
       perceived would not justify this measure.

264 They went on to state, however:

       We consider that manufacturers of baby foods should avoid the use of
       ruminant offal and thymus.

We shall from now on describe this piece of advice as ‘the baby food
recommendation’.

265 There were a number of matters which the Working Party did not explain in
their Report:

   •   What did they mean when they said that the risk of transmission of BSE to
       humans appeared ‘remote’?
   •   Why did they consider that the risk appeared remote?
   •   Why did they recommend that affected cattle should be slaughtered
       and destroyed?
   •   Why did they make the baby food recommendation?
   •   Why did they not recommend any other precautions to protect human food
       from subclinically infected animals?

266 All these matters we raised with the members of the Working Party.
                                                                                      51
FINDINGS AND CONCLUSIONS


         267 They explained that they intended the word ‘remote’ to bear the meaning that
         this word has when used to describe a risk in a medical context. In that context a
         remote risk is one that is highly unlikely to prove significant, but which it is
         unreasonable to ignore. Reasonable precautions should be taken to try to prevent a
         remote risk. The Working Party set out to advise what those precautions should be.
         They told us that in doing so:

                Our approach to risk was in accord with the then developing application of
                analysis to public risk which involved the balancing of the perceived
                magnitude of the risk against the practicability or achievability of successive
                steps for its reduction. The magnitude of a risk comprises both its likelihood
                and the scale of the danger.

         268 This approach is sometimes known as ALARP (As Low As Reasonably
         Practicable). It requires an exercise in proportionality. When deciding whether a
         precaution is ‘reasonably practicable’ it is necessary to weigh the cost and
         consequences of introducing the precaution against the risk which the precaution is
         intended to obviate.

         269 Why was the risk considered remote? Our reading of the Report led us to
         conclude that the Working Party had drawn comfort from the way that scrapie
         behaves. Sheep infected with scrapie have been slaughtered for human food for
         hundreds of years, without doing any harm. If BSE was the scrapie agent in cattle,
         it was likely that it would behave in the same way.

         270 The Working Party confirmed to us that this was indeed their reasoning.
         But they emphasised that they did not assume that BSE would behave like scrapie.
         They recognised the possibility that, whether or not scrapie was the source of the
         infection, BSE in cattle might behave more virulently than scrapie in sheep.
         Because of this possibility, reasonable precautions needed to be taken against
         the possible risk from eating BSE-infected meat.

         271 The Working Party concluded that reasonable precautions against the risk
         from eating BSE-infected meat involved taking sick animals out of the food chain,
         but that no precautions were needed in respect of subclinically infected animals,
         other than the baby food recommendation.

         272 We have a number of criticisms to make of this part of the Working Party’s
         Report. In the first place they did not make it clear that, in describing the risk as
         remote, they were intending to indicate that steps should be taken to reduce the risk
         as low as reasonably practicable. We think that they should have done.

         273 In the second place, we do not consider that the Working Party correctly
         applied the ALARP principle. Animals with BSE that had developed clinical signs
         of the disease were to be slaughtered and destroyed. No steps were to be taken,
         however, to protect anyone other than babies from the risk of eating potentially
         infective parts of animals infected with BSE but not yet showing signs. It is true
         that infectivity of the most infective tissues – the brain and spinal cord – rises
         significantly shortly before clinical signs begin to show. It is also true that there
         were reasons to think that babies might be more susceptible to infection than adults.
         But we do not consider that these differences justified an approach that treated the
52
          THE SOUTHWOOD WORKING PARTY AND OTHER SCIENTIFIC ADVISORY COMMITTEES


risk from eating brain or spinal cord from an animal incubating BSE as one in
respect of which there were no reasonably practical precautions that need be taken.

274 We believe that part of the Working Party’s problem was that they were in no
position to reach an informed view of how the ALARP principle should apply. They
were not aware of the practice of mechanical recovery of meat, which sucked from
the spinal column the residue left attached after removal of meat – a residue likely
to include portions of spinal cord. Nor, so we believe, did they have in mind that it
was reasonably practicable to identify and remove the potentially infective tissues
in the course of the slaughterhouse processes.

275 In these circumstances, we do not criticise the Working Party for failing to
recommend the precautionary measure that MAFF was subsequently to put in place
– the SBO ban. What we feel they should have done was to point out that cattle
subclinically infected with BSE were entering the human food chain, that some
tissues of such cattle were potentially infective, and that consideration should be
given to identifying such steps as were reasonably practicable to prevent their being
eaten, not just by babies, but by everyone.

276 There is a further aspect of the way the Southwood Report dealt with risk that
caused us concern. The Working Party said of the risk of transmission of BSE
through the use of medicinal products:

       Although the risks appear remote the Working Party recommended that the
       attention of the Licensing Authority, the Committee on Safety of Medicines,
       the Committee on Dental and Surgical Materials and the Veterinary Products
       Committee be drawn to the emergence of BSE so that they can take
       appropriate action.

277 The Working Party told us that they had described these risks as remote only
because of the action that they had been assured was being taken to address them.
They had initially considered that some medicinal products sourced from bovine
materials, which were injected, might carry a relatively high risk of transmission.
With the assistance of Dr Pickles they had taken all proper steps to get those
responsible for the safety of medicines to start taking action to address this risk.
They had intended to include in their Report details of some of the steps that could
be considered to prevent the BSE agent entering into pharmaceutical manufacture.
However, as we describe in paragraphs 901–906 below, in response to concerns
expressed by officials responsible for medicines licensing, they had been persuaded
to tone down their Report and make no mention of these by the assurance that action
was being taken.

278 The action taken by the Working Party, assisted by Dr Pickles, to galvanise
those responsible for the safety of medicines was praiseworthy. The Working Party
told us that they were anxious to avoid raising, by their Report, concerns about the
safety of vaccines that would lead to a vaccine scare which could result in children
being exposed to much greater risk than that posed by BSE. We sympathise with
their anxiety. It led, however, to their Report giving the reader a false impression of
their assessment of the risk relating to medicinal products. The Working Party
should not have allowed this. They could have avoided doing so, without creating a
vaccine scare, simply by saying that they had had concerns about the implications
that BSE might have for certain medicinal products and had referred those concerns        53
FINDINGS AND CONCLUSIONS


         to the Committee on Safety of Medicines and the Veterinary Products Committee,
         which had undertaken to address them. Unfortunately, the wording of the Report
         was to give some who were responsible for dealing with medicinal products, both
         human and veterinary, the impression that these would involve no more than a
         remote risk, even if no remedial measures were taken.

         279 Similarly, the sections of the Report that dealt with occupational safety gave
         the impression that occupational risks were remote whether or not steps were taken
         to address them. The Working Party had commendably taken steps before
         publication of their Report to ensure that occupational risks were addressed.
         Dr Pickles had written to, and met with, the Health and Safety Executive (HSE) on
         their behalf. Their Report recommended that the HSE consider whether further
         guidance should be given. However, it seemed to us that the effect of this
         recommendation was likely to be uncertain, given the indications in the body of the
         Report that the risk was remote and that no specific additional guidance on BSE was
         thought necessary. As with medicines, we consider that the Working Party should
         not have used words that conveyed the impression that the risks were, even in the
         absence of precautionary measures, remote.

         280 By the time that the Working Party came to finalise their Report, their interim
         recommendation that an expert committee be set up to advise on research had been
         implemented. The Tyrrell Committee had been established. In their Report the
         Working Party drew attention to a number of areas where research was needed for
         further consideration by that Committee. They also recommended the monitoring
         of CJD cases, since any human cases of BSE would probably present as CJD.
         The achievement of the CJD Surveillance Unit in identifying in 1996 the emergence
         of variant CJD demonstrated the wisdom of this recommendation.

         281 The draft of the Working Party’s Report had a sting in its tail. It referred to the
         fact that BSE had resulted from the practice of feeding animal protein to herbivores,
         and noted that this practice opened up new pathways for infection. It continued:

                We believe that the inevitable risks are such that it would be prudent to
                change agricultural practice so as to eliminate these novel pathways
                for pathogens.

         282 When MAFF officials learned that this was to be included in the Report they
         were horrified, as they read it as an attack on the practice of incorporating MBM in
         animal feed. Animal Health Division commented to the Permanent Secretary that
         the rendering industry processed over 100,000 tonnes of raw material every month,
         thus providing a source of animal feed and industrial raw material, and also a
         ‘waste disposal’ service for the slaughtering industry. A paper setting out those
         implications was quickly prepared and sent to the Working Party. Dr Martin also
         wrote to Sir Richard, urging restraint on this topic. Restraint there was, for an
         amendment was made to the draft which was intended to make clear something that
         Sir Richard later confirmed. The Working Party was not recommending that the
         practice of rendering animal protein should cease, but that its continuance should
         depend upon finding a rendering process capable of destroying all pathogens.

         283 We have criticised some aspects of the Southwood Report, but those criticisms
         should not obscure the vital benefit that the Working Party provided in putting an
54       immediate stop to the practice of eating BSE-diseased animals, in bringing
                THE SOUTHWOOD WORKING PARTY AND OTHER SCIENTIFIC ADVISORY COMMITTEES


immediate pressure to bear on those responsible for the safety of human medicines
and occupational health to address the risks posed by BSE, and in giving wise
advice about research. When the Report was published, it was generally well
received by those who were expert in the field. Nonetheless a number of experts
raised, at the time, the question of the risk posed by subclinical animals, and many
more, when giving evidence to us, claimed to have identified the need to address
this problem at the time. Pressure to do so was soon to build up and lead to the
decision to introduce the SBO ban.

284 The Working Party’s risk assessment had, necessarily, been based on very
limited data. In August 1988 Sir Richard, replying to a medical correspondent,
wrote:

           My colleagues and I have made various recommendations based, I have to
           admit, largely on guesswork and drawing parallels from the existing
           knowledge of scrapie and CJD.

In a summary section of their Report, the Working Party wrote:

           Our deliberations have been limited by the paucity of the available evidence.
           Further research work in this area is essential.

In their General Conclusions, after observing that it was most unlikely that
BSE would have any implications for human health, the Working Party added
this warning:

           Nevertheless, if our assessment of these likelihoods are incorrect, the
           implications would be extremely serious.

285 Unfortunately, this warning and the tentative nature of the Working Party’s
conclusions were not appreciated or were lost sight of. Right up to 1996 the
Southwood Report was cited as if it demonstrated as a matter of scientific certainty,
rather than provisional opinion, that any risk to humans from BSE was remote.



Other scientific advisory committees

The Consultative Committee on Research into SEs
(The Tyrrell Committee)27

286 One of the first recommendations to be made by the Southwood Working
Party in June 1988 was that an expert Consultative Committee on research should
be set up. In February 1989 it was announced that, following this recommendation,
a Consultative Committee had been set up, chaired by Dr David Tyrrell.28 The other
members were Dr Watson,29 Professor John Bourne,30 Dr Robert Will,31 and
Dr Richard Kimberlin.32 The terms of reference were:
27
     Detailed consideration of the work of The Tyrrell Committee appears in vol. 11: Scientists After Southwood
28
     A microbiologist who was Director of the MRC Common Cold Unit
29
     Director of the Central Veterinary Laboratory
30
     Director of the Institute for Animal Health
31
     Consultant Neurologist at the Western General Hospital Edinburgh
32
     Ex-Acting Director of the NPU, who had retired to set up an independent consultancy, advising on TSEs        55
FINDINGS AND CONCLUSIONS


                To advise the Ministry of Agriculture, Fisheries and Food and Department
                of Health on research on transmissible spongiform encephalopathies
                including:

                        (a)   work already in progress or proposed;

                        (b)   any additional work required;

                        (c)   priorities for future relevant research.

                In the context of these terms of reference, transmissible spongiform
                encephalopathies include those affecting both domestic and wild ruminants
                and man.

         287 The Committee moved fast. After three meetings it presented an ‘Interim
         Report’ to the Government on 10 June 1989. This identified a number of research
         questions that needed to be answered about BSE under the headings: epidemiology,
         pathology and molecular studies. Research studies needed to answer these questions
         were identified and graded with three stars for highest priority, two stars for medium
         priority and one star for low priority. We consider the adequacy of the research
         carried out into BSE in Chapter 12 below.

         288 In commenting on the research questions, the Committee observed:

                We need to be sure that the disease really came from sheep and to know
                whether it is likely to establish itself long-term in bovines.

         289 In their conclusions the Committee stressed that more research was needed:

                If the preliminary studies and arguments-by-analogy used to determine our
                present control policies turn out to be incorrect, it will be essential to have
                well-documented facts available so that current policies can be effectively
                revised.

         290 The Report was produced in haste as an interim one because the Committee
         was anxious that there should be no delay in seeking provision of resources for
         essential research and getting the projects under way. The Committee emphasised
         the importance of having the projects peer-reviewed and suggested that:

                A standard mechanism may be needed to oversee this co-operation and
                co-ordination beyond the lifetime of our Committee.

         291 The Committee asked for guidance as to whether they were expected to have
         a continuing role in peer review and project coordination.

         292 Mr Gummer decided that the Government should respond to the Tyrrell Report
         by initiating all research projects falling within the top two of the Tyrrell
         Committee’s priority categories, and Mr Roger Freeman, Parliamentary Under-
         Secretary at DH, conveyed to him his Department’s agreement with this response.
         Delay then occurred in ensuring that the necessary funding was in place. This was
         not achieved until January 1990, when the Government published the Report and
56       announced that work was in hand to implement the projects recommended by the
          THE SOUTHWOOD WORKING PARTY AND OTHER SCIENTIFIC ADVISORY COMMITTEES


Tyrrell Committee as urgent and of high priority, some of which were already in
progress. It is creditworthy that Mr Gummer, in accordance with the advice of his
officials, proffered by Mr Andrews, and with the support of DH, decided that all
these projects should be pursued.

The Spongiform Encephalopathy Advisory Committee
(SEAC)

293 No further assistance was sought from the Tyrrell Committee. Officials at
MAFF and DH agreed that it was desirable that a new expert standing committee
should be formed to meet from time to time to advise on questions about BSE, but
that this new committee should not publish reports. Its role would include having a
general overview of research. Dr Tyrrell was invited, and agreed, to chair this new
committee. Mr Gummer announced the setting up of SEAC on 3 April 1990.
Its terms of reference were:

       To advise the Ministry of Agriculture, Fisheries and Food and the
       Department of Health on matters relating to spongiform encephalopathies.

294 A detailed account of the setting up, membership and activities of SEAC
appears in Volume 11, together with discussion on its role. In this volume we shall
refer from time to time in the course of the narrative to questions asked of, and
advice given by, SEAC. Contrary to the expectation, and to some extent the wishes,
of its members, SEAC found itself given the role of providing policy advice on
almost every decision that the Government was faced with in handling BSE.

295 We should record our respect for the dedication of the members of both the
Tyrrell Committee and SEAC. Members of the latter found themselves called upon
to provide much more assistance than they had been led to believe would be the
case. Independent scientists in this country have an admirable tradition of agreeing
to serve on committees performing functions in the public interest. Members of
SEAC, who exemplified this tradition, found that it involved a considerable burden.




                                                                                       57
     5. The animal health story
     296 By the time that the Southwood Report was published, the two major measures
     that the Working Party had recommended were in place. The ruminant feed ban had
     been extended – not indefinitely as the Working Party had recommended, but for a
     further year. An indefinite extension was to come later. If feed were the only means
     of infecting with BSE, the ban should in due course eradicate the disease. So far as
     the risk to humans was concerned, the Working Party considered that slaughter and
     destruction of animals showing clinical signs sufficed to protect against the remote
     risk of transmission as a result of eating infective tissue. So far as occupational risks
     and risks in relation to medicinal products were concerned, the Working Party had
     alerted those responsible for addressing these.

     297 Substantial further measures were, however, to be taken to address food risks,
     for both humans and animals. These were, first, the ban on using Specified Bovine
     Offal (SBO) for human food (‘the human SBO ban’), followed by a ban on
     incorporating SBO in animal feed (‘the animal SBO ban’). Our task of reviewing
     the action taken in response to BSE up to 20 March 1996 requires us to examine the
     circumstances in which these measures were introduced. It also requires us to
     review the various measures that were taken in response to BSE and how they were
     enforced and monitored. That is a complex, but important, part of the BSE story. It
     is important because there were significant shortcomings in both the human health
     and the animal health measures, and in their enforcement and monitoring. Had we
     attempted to cover all of this in simple chronological order in our Report, the result
     would have been to confuse. Accordingly we decided at this stage to divide our
     coverage into two. In Volume 5 we have traced the story of measures taken to
     protect animal health. In Volume 6 we have followed the story that relates to the
     protection of human health.

     298 We propose to follow the same course in this volume. In this chapter we shall
     cover that part of the story which is told in detail in Volume 5. We shall moreover
     subdivide the topics in the same way as we have in that volume. This means that we
     shall give separate treatment to the ruminant feed ban and the animal SBO ban. The
     former was the measure designed to protect cattle and other ruminants. The latter
     was designed to protect non-ruminant animals, but provided fortuitously an
     additional line of defence for cattle, which proved of great importance.

     299 It may be thought that we have got our priorities wrong in considering animal
     health before human health. The reality is that, although introduced in the interests
     of animal health, the action taken to eradicate BSE was of critical importance in
     protecting humans should BSE prove, as indeed it did, to be a zoonosis. It is for this
     reason that we considered it logical to look first of all at that part of the BSE story
     which was motivated by the immediate demands of animal health.




58
                                                                                                     THE ANIMAL HEALTH STORY


Ruminant feed ban

300 Mr Kevin Taylor33 became responsible for providing veterinary advice on all
aspects of the control of BSE from the time that it became a notifiable disease in
1988. He told us that there was no practical way in which the ruminant feed ban
could be enforced, as there was no test which could identify rendered ruminant
protein in animal feed. Effectiveness depended on voluntary compliance with the
ban. Because of the long incubation period, years would elapse before it would
become apparent whether there had been strict compliance with the ruminant feed
ban. We consider that it was reasonable to expect that neither feedmills nor farmers
would deliberately incorporate MBM in cattle feed. Other sources of protein were
available that were only marginally more expensive.

301 No guidance was given to the County Councils and Unitary Authorities, whose
duty it was to enforce the ban. We had evidence which suggested that some local
authorities made attempts to check on compliance with the ruminant feed ban by
sampling, but found this impossible. It is possible that others may have checked the
records of feedmills to ensure that MBM was not a component of cattle feed,
although strictly they had no statutory right to demand to see these.34 In general we
do not believe that any steps were taken by local authorities to enforce the ban
during any part of the period with which we are concerned.

302 Mr MacGregor proposed that the introduction of the ruminant feed ban should
be handled in a low-key way on the assumption that MAFF had a system for
notifying all those who were affected, and in particular farmers. In the event MAFF
officials made no attempt to contact renderers, the feed trade or farmers directly, but
relied upon meetings with trade associations, or farmers’ unions, together with a
press release, in order to publicise the introduction of the ban.35

303 Representatives of the feed industry told us that when the feed ban was
introduced, a number of factors combined to detract from any impression of
urgency about its implementation:

     •     the grant of a period of grace in which to use up current stocks of feed;
     •     the absence of any feed recall;
     •     the fact that neither import nor export of MBM was to be prohibited;
     •     uncertainty as to whether MBM was indeed the vector of BSE and, if it was,
           as to which rendering systems were unable to inactivate it; and finally,
     •     the belief that a very large amount of infective feed would have to be
           consumed to transmit the disease.

304 Farmers who gave evidence told us that they did not appreciate the gravity of
the situation at the time. It was only the occasional farmer who had experience of
BSE and that experience was normally of no more than a single case. They
continued to use up any stocks of cattle feed remaining at the time that the ban came
into force.36
33
     Veterinary Head of Notifiable Diseases Section, 1986–91; Assistant Chief Veterinary Officer, Animal Health and Welfare
     Veterinary Section, 1991–97
34
     Vol. 5: Animal Health, 1989–1996, Chapter 2, paras 2.10 and 2.43
35
     Vol. 5: Animal Health, 1989–1996, Chapter 2, paras 2.31–2.35
36
     Vol. 3: Early Years, 1986–88, paras 4.86–4.113                                                                           59
FINDINGS AND CONCLUSIONS


         305 A relatively relaxed attitude to enforcement of the ban was illustrated by the
         decision of Mr Meldrum in February 1989 that the development of an ELISA test,
         to detect the presence of ruminant protein in animal feed, should be carried out ‘in
         house’ by a senior scientific officer at Worcester VIC, Mr Mike Ansfield. This
         course had a number of attractions, not least that MAFF would retain the intellectual
         property in the test, which might prove commercially valuable. It was estimated,
         however, that it would take between 12 and 18 months to develop the test. The more
         costly alternative of seeking external collaboration in producing a test would have
         been likely to produce swifter results.37 As we have commented above, this attitude
         was a consequence of a failure to appreciate the need to guard against cross-
         contamination of cattle feed.

         306 Although no anxieties were expressed about the adequacy of the action taken
         by MAFF to eradicate BSE, there were concerns about the risk that BSE might pose,
         in the interim, to humans and to non-ruminant animals. The scale of infection of
         cattle during the period before the ruminant feed ban was introduced proved to have
         been greatly underestimated. By the end of 1988 cases were being reported and
         confirmed at a rate of over 100 cases a week. The Southwood Working Party had
         envisaged cases remaining on a plateau at about that rate, but by the end of April
         1989 the rate had increased to about 150 cases reported each week. In June 1989 the
         Government announced its intention to ban SBO (brain, spinal cord, tonsils,
         thymus, spleen and intestines) from all human food (‘the human SBO ban’). This
         led a large part of the feed industry to impose a voluntary ban on including those
         categories of offal in animal feed, a ban that MAFF made statutory in September
         1990 (‘the animal SBO ban’) after a number of cases of Feline Spongiform
         Encephalopathy (FSE) had been identified and BSE had been experimentally
         transmitted, by inoculation, to a pig. Those events are dealt with later in this chapter.

         307 The first case of FSE in May 1990 led to considerable public concern about
         its implications for human health and to an Inquiry into BSE by the Agriculture
         Committee of the House of Commons. The primary concern of the Committee was
         the implications of BSE for human health. So far as animal health was concerned,
         the Committee observed that the ruminant feed ban, if strictly applied, should arrest
         BSE. They recommended, however:

                    That the Government establish an expert committee to examine the whole
                    range of animal feeds and advise on how the industries that produce these
                    should be regulated.

         308 This recommendation was accepted by the Government, which set up the
         Lamming Committee (the Expert Group on Animal Feedingstuffs) in 1991.

         309 By the end of 1990 MAFF officials and Mr Gummer, now the Minister of
         Agriculture, Fisheries and Food, had no reason to doubt the efficacy of the ruminant
         feed ban. The rate of reported cases had soared until in some weeks these exceeded
         400, but they were all cases of cattle born before the ruminant feed ban came into
         force. Mr Ansfield appeared to have made substantial progress in the development
         of an ELISA test. His test could detect both ovine and bovine protein in meat and
         bone meal (MBM). It remained to test it on compound feed.


60       37
              Vol. 5: Animal Health, 1989–1996, Chapter 2 paras 2.52–2.54
                                                                                                    THE ANIMAL HEALTH STORY


310 The development of the ELISA test resulted in some concern on the part of
UKASTA. It feared that the test would identify small quantities of ruminant protein
in cattle feed resulting from cross-contamination with pig and poultry rations in the
feedmills, or from traces in tallow incorporated in cattle feed. Its concern was not
that this would be sufficient to infect cattle, but that it might result in prosecution of
its members for breach of the Regulations. This concern was conveyed by Dr Danny
Matthews38 to Mr Meldrum. He told us that at this point he did not recall any
concerns at MAFF that cross-contamination of feed might be taking place on a scale
sufficient to undermine the effectiveness of the ruminant feed ban.

The first BAB

311 On 22 March 1991 the first BAB39 was reported to Mr Gummer. This was
made public by a news release five days later. It caused considerable excitement
within MAFF as urgent consideration was given to whether it was a case of maternal
transmission or whether it might have been infected by feed. It was, however, only
the first of what was to become first a trickle, then a stream and finally a flood. By
the end of the year 300 BABs had been reported, of which only 11 had been
confirmed. Investigations by Dr Matthews and his colleagues suggested that at least
the majority of these cases were caused by feed containing MBM that was still in
the feed chain when the ban came into force on 18 July 1988.

312 The Lamming Committee40 met for the first time on 15 February 1991. At their
second meeting on 13 March they heard evidence from Mr Meldrum. He told them
that he was not totally content with the current controls, as at

           . . . present there was no test for ruminant protein in feed. However, an
           ELISA method was currently being evaluated for use in the field.

313 He said that he was fairly confident that on-farm mixers would observe the
controls, despite the absence of a test.

314 Unfortunately, hopes that the ELISA test was almost ready for use were
dashed when it was found that most compound feeds produced a positive result even
when they included no MBM.

315 When the Lamming Committee reported in June 1992, they commented about
BSE that the evidence suggested that in the majority of cases the controls were
working, despite the fact that the ruminant feed ban and the SBO ban were to a
considerable extent dependent on self-regulation by the industry. They welcomed
the development of the ELISA test.

316 As the number of BABs increased, so did MAFF officials’ conviction that feed
containing ruminant protein had been fed to cattle for a significant period after the
ban came into force. In September 1992 Dr Matthews minuted Mr Meldrum
commenting that it was clear that the major compounders had needed at least three
months to clear stocks, in some cases longer. He added that smaller compounders,
who were disproportionately represented among suppliers to owners of BAB cases,
38
     The Senior Veterinary Officer at Tolworth responsible for BSE
39
     BSE victim Born After the ruminant feed Ban came into force
40
     Professor G E Lamming, Professor of Animal Physiology, Nottingham University; Professor P C Thomas, Principal and
     Chief Executive, Scottish Agricultural College; Mr C Maclean, Technical Director, Meat and Livestock Commission; and
     Dr E M Cooke, Deputy Director, Public Health Laboratory Service                                                        61
FINDINGS AND CONCLUSIONS


         having not been party to discussions prior to the introduction of the ban, might be
         expected to have taken longer to clear their stocks.

         UKASTA’s information about breaches of the ban

         317 By this time 220 BABs had been confirmed. Mr Meldrum wrote to Mr James
         Reed, the Director-General of UKASTA, suggesting that there had been a time lag
         of between three and six months before the ban became fully effective. In response
         to Mr Meldrum’s request for information, UKASTA asked all companies
         represented on its Executive Committee to answer a questionnaire. At a meeting on
         10 November, they gave Mr Meldrum the results of this survey, on condition that
         the information would be treated with the utmost confidence. The survey showed
         that most compounders had continued to manufacture cattle feed containing
         ruminant protein into July 1988 and did not clear stocks from their premises until
         August or September, or even, in a few instances, October. When giving evidence
         to us, UKASTA representatives suggested that the stocks of cattle feed may have
         been cleared by incorporation in feed for non-ruminants, so that the survey may not
         have disclosed deliberate breach of the ban by UKASTA members. We reject this
         suggestion, as did Mr Meldrum. The contemporary evidence of the meeting on
         10 November is unequivocal. That evidence is reinforced by the fact that over
         11,000 cattle born in the last five months of 1988 contracted BSE, as did a further
         12,600-odd that were born in 1989.

         318 These figures will, of course, reflect the use by farmers after 18 July 1988 of
         feed purchased before that date, but we are satisfied that they also reflect deliberate
         breaches of the ban by some compounders and others in the supply chain. As a
         whole the animal feed industry does not emerge from the BSE story with credit.

         319 MAFF officials seized eagerly on evidence of breaches of the ruminant feed
         ban, for the alternative explanation that maternal transmission was occurring was
         less palatable. In November Ministers were told that there was clear evidence that
         ruminant feed containing MBM would have been available for six months after the
         ban came into force. At the year end a MAFF progress report expressed continued
         confidence that the ban would bring the epidemic to an end.

         320 The first half of 1993 saw MAFF officials frustrated in their desire to start
         testing feed for the presence of animal protein by continuing difficulties in
         developing the ELISA test – accentuated by suspension of work on the project while
         the Worcester VIC was relocated to Luddington. MAFF’s difficulties were
         compounded by the fact that they had no legal power to carry out random sampling.
         Samples could only be taken when there were reasonable grounds for suspecting
         that the Regulations were being broken. The lengthy incubation period made it
         difficult to demonstrate such grounds.

         321 In September a briefing paper prepared for Mrs Gillian Shephard, who had
         succeeded Mr Gummer in July as the MAFF Minister, and Mr Nicholas Soames, the
         Parliamentary Secretary at MAFF, stated that there had been 4,010 confirmed
         BABs, the great majority of which had had access to ruminant protein in their feed.
         The paper went on to make the point that the animal SBO ban introduced in 1990
         had had the effect of reinforcing the ruminant feed ban.
62
                                                                      THE ANIMAL HEALTH STORY


322 Problems in relation to sampling continued in the first half of 1994. The
ELISA test was ready for field testing, but sampling capacity at Luddington was
limited and there was no hope of embarking on large-scale monitoring at feedmills.
Furthermore, the lawyers were having difficulty finding a path through the maze of
different Regulations relating to animal feed that would enable mandatory sampling
to be introduced.

323 Towards the end of 1993 Mr Wilesmith had begun to feel concerned that cross-
contamination might be taking place at feedmills manufacturing multi-species
rations. This concern was taken up by Mr Bradley early in the following year. In a
minute to Mr Kevin Taylor, he commented that they had both believed that the
animal SBO ban would have stopped any infected ruminant protein getting through
into the animal feed chain, but if the SBO ban was being abused there was a
weakness in this argument. It was at this time that concern was growing about
reports of non-compliance with the animal SBO ban.41

324 By the middle of 1994 MAFF officials had worked out a sampling procedure
which they recommended in a submission to Mr Soames. Sampling of cattle feed
should initially be carried out on farms on a voluntary basis. Any positive results
would lead to mandatory sampling at the feedmill which had supplied the feed.
MAFF would carry out the testing themselves rather than entrusting the ELISA test
to the local authorities, which had statutory responsibility for enforcing the ban.
There were a number of reasons why MAFF officials wished to keep the testing ‘in
house’ – one being apprehension that some local authorities might prove over-
assiduous in enforcing the ban. It seems to us that the test was not sufficiently robust
at this stage to be used in statutory enforcement of the ban. The decision of MAFF
officials that MAFF should use the test on a voluntary basis under a uniform scheme
to operate across the country was reasonable.

Cross-contamination in feedmills

325 In June 1994 the possibility that cross-contamination in feedmills was a cause
of some of the BABs was discussed with UKASTA’s Scientific Committee. They
commented that equipment used in feedmills was being updated ‘as and when
required’. This was the start of a series of meetings between MAFF officials and
UKASTA in which each had a similar hidden agenda. MAFF was concerned not to
do anything that would lead UKASTA members to cease using animal protein as an
ingredient of feed for non-ruminant animals. UKASTA, for its part, was anxious
that its members should be able to continue to do this without incurring risk of
prosecution should it result, on occasion, in cross-contamination of ruminant feed.
UKASTA was to threaten repeatedly that it might have to advise its members to
cease using animal protein, while MAFF officials sought to allay UKASTA’s
anxieties by reassuring its members that sampling was not being used as a precursor
to prosecution. In reality, the limitations of the ELISA test, coupled with the
requirement under the Order to prove knowing incorporation of ruminant protein,
meant that MAFF officials were in no position to contemplate enforcing the
ruminant feed ban by criminal proceedings.




41
     See paras 441ff                                                                       63
FINDINGS AND CONCLUSIONS


         326 In July 1994 Mr William Waldegrave succeeded Mrs Shephard as Minister of
         Agriculture, Fisheries and Food. The following month he was informed of the first
         four BABs to be reported that had been born in 1991.

         327 By September 1994 a number of factors had combined to indicate that cross-
         contamination in feedmills was a serious problem:

            •   Inactivation studies had shown that the three systems which provided most
                of the UK rendering capacity were not capable of inactivating the BSE agent.
            •   Epidemiological investigations had revealed a correlation between the
                incidence of BABs and the ratio of cattle to pigs in the different counties.
                The incidence of BABs was highest in those counties where mills were
                producing both pig and cattle feed in large quantities. Mr Wilesmith
                concluded that cross-contamination was likely to be occurring at the mills
                rather than on the farms, although he recognised that cross-contamination on
                the farm was possible.
            •   There was clear evidence of failures to comply with the requirements of the
                animal SBO ban.
            •   Four BABs born in 1991 had been confirmed.
            •   Voluntary on-farm ELISA testing had produced the first positive result.
            •   Interim results of MAFF’s attack rate experiment had shown that 1 gram of
                infective material was sufficient to transmit BSE when administered orally.

         328 This last factor produced a radical change of attitude on the part of both
         MAFF and UKASTA to the dangers of cross-contamination of feed. In reporting to
         Mr Waldegrave on 21 November 1994, Mr Richard Packer, the Permanent
         Secretary at MAFF, stated:

                The trade’s protestations that cross-contamination never occurred have been
                reversed; they are now more or less telling us that where the same mill is
                used for ruminant and non-ruminant feed, some cross-contamination is
                inevitable, although this is usually at low levels.

         329 Mr Packer had plainly been misinformed. UKASTA had expressed concern
         about cross-contamination at the outset, but had been led to believe that this would
         not matter because a large quantity of infective material had to be eaten in order to
         result in infection.

         330 At this point UKASTA appeared to come closest to advising its members to
         cease using MBM in feed. It attempted to elicit from MAFF an assurance that the
         rendering processes would produce MBM that was ‘safe’. Mr Packer was not
         prepared to provide this. However, he did produce for UKASTA a statement
         summarising the steps MAFF had taken to prevent transmission of BSE to cattle.
         This emphasised that the controls over the implementation of the animal SBO ban
         were being strengthened and that more effective rendering processes were being
         adopted. The statement ended:

                The Ministry considers there to be no reason in principle why [ruminant
                protein] should not continue to be used in non-ruminant feed, even in
64
                                                                      THE ANIMAL HEALTH STORY


          premises preparing feed for ruminant and non-ruminant species, provided
          that steps are taken to prevent accidental inclusion in ruminant rations.

UKASTA accepted this statement as satisfactory reassurance and the use by its
members of MBM in non-ruminant feed continued.

331 We had evidence from some of the major feed compounders that once they
had been made aware that cross-contamination was a cause for concern, they took
steps to identify the critical control points and to modify their production lines so as
to reduce the risk of contamination occurring. UKASTA and MAFF reached
agreement under which compounders were permitted, under a quota system, to
submit samples to Luddington for ELISA testing in order to check that their
production was free of contamination. This sampling was carried out in parallel
with sampling by MAFF of feed on farms on a voluntary basis. Mr Meldrum told
us of at least one occasion on which this led to the identification of a mill where
cross-contamination was occurring, and to the mill in question taking steps to
remedy the problem. Problems were, however, still being experienced with the
ELISA test and it was apparent to both MAFF and UKASTA that it was capable of
giving false positives and false negatives.

332 As at 23 January 1995, the number of confirmed BABS had risen to 15,771,
of which 812 had been born in 1990 and 9 in 1991. In the following month it was
confirmed that the attack rate study had demonstrated that 1 gram of material was
sufficient to produce oral transmission. When this was reported to Mr Waldegrave,
he asked whether further steps needed to be taken to ensure that compounders’
feedlines were clean. Mr Meldrum replied that the short answer was ‘No’. The
important thing was to prevent infected material entering the feedlines. As to this,
the only action that he could recommend was to continue to intensify controls on
the disposal of SBO. Mr Waldegrave accepted this advice.

333 In May 1995 MAFF officials were giving consideration to arranging advisory
visits to feedmills in order to give guidance on how to avoid cross-contamination
and, at the same time, to replacing voluntary sampling on farms with unannounced
sampling visits to mills. Our impression is that UKASTA was less than enthusiastic
about these proposals. Its first duty was to protect its members’ interests and it
showed a continued awareness of the need to protect its members from the risk of
prosecution. However, consideration of voluntary visits and sampling was
overtaken by a Decision of the European Commission42 adopted on 18 July 1995.
This required routine monitoring of feedmills, and in particular of mills which
produced both ruminant and non-ruminant feed, to include official ELISA tests for
the presence of animal protein.

334 Discussions with UKASTA about implementing this Decision did not receive
an enthusiastic response. UKASTA did, however, cooperate in the drafting of a
letter from MAFF to all manufacturers and mixers of feedstuffs, drawing attention
to the need to avoid cross-contamination and giving guidance on how to do so. We
found this a bland document. In particular it made no mention of the fact that
experiments had demonstrated that as little as 1 gram of infective material could
result in oral transmission of BSE. A revised Advisory Note directed specifically to
farmers was drafted by MAFF in November 1995. This was an admirable document
giving detailed advice on all the different ways in which feed might become
42
     Commission Decision 95/287/EC                                                         65
FINDINGS AND CONCLUSIONS


         contaminated on the farm or in the course of farm mixing. Unfortunately, this draft
         got bogged down in the course of the consultative process, involving input from the
         Spongiform Encephalopathy Advisory Committee (SEAC) and the Parliamentary
         Secretary, and had not been sent out when it was overtaken by events in March
         1996. This was one of a number of examples in the BSE story of the best being the
         enemy of the good.

         335 By 24 August 1995 the number of confirmed BABs had risen to 21,475, of
         which three had been born in 1992. Although it was not initially appreciated, the
         effect of the Commission Decision requiring mandatory sampling of feed was to
         give MAFF officials the right to enter mills and carry out the sampling. An Animal
         Health Circular was drafted instructing State Veterinary Service staff on measures
         to implement the mandatory sampling regime, which was initiated early in 1996.
         Although the ELISA test was still not perfected – we understand that it remains
         imperfect to this day – the first round of tests produced four positive results from
         25 mills tested.

         336 On 6 July 1995 Mr Douglas Hogg succeeded Mr Waldegrave as Minister of
         Agriculture, Fisheries and Food. One of his first acts was to introduce the Specified
         Bovine Offal Order 1995 which, as we explain later in this chapter, dramatically
         improved the regime for enforcing the animal SBO ban. Later in the year, Mr Hogg
         discussed with Mr Meldrum whether further measures should be taken in the
         feedmills to address the risk of cross-contamination. Mr Meldrum explained that
         mandatory sampling was to be introduced and advised that it would not be practical
         to require feedmills to set up separate production lines for ruminant and non-
         ruminant feed. Mr Hogg accepted this advice.

         337 SEAC reviewed from time to time the implications of the BABs and the action
         that MAFF officials were taking to address the cause of infection.43 The Committee
         urged the importance of the development of the ELISA test, but in general endorsed
         the action that MAFF was taking. On the identification of the probable link between
         BSE and the new variant cases of CJD, SEAC’s attitude changed. Members
         considered that it was of paramount importance to bring the BSE epidemic to a close
         as swiftly as possible, thereby protecting both animal and human health. To achieve
         this SEAC proposed a ban on the use of all meat and bone meal of mammalian
         origin in farm animal feed. This would remove all possibility of the contamination
         of ruminant feed. The Government accepted this advice and gave effect to it on
         29 March 1996.44

         338 As at end-June 2000 the number of confirmed BABs stood at 41,538. Of those
         179 were born in 1995 and 2 in 1996. For each confirmed case, several will have
         been slaughtered before developing clinical symptoms. Almost all of these cases
         will have resulted from eating MBM derived from apparently healthy animals,
         because animals showing signs of BSE were being slaughtered and destroyed.

         What went wrong?

         339 When looking back with the benefit of hindsight, we have identified a number
         of things that went wrong in the history of the ruminant feed ban.

         43
              See Volume 11
66       44
              The Bovine Spongiform Encephalopathy (Amendment) Order 1996
                                                                                                         THE ANIMAL HEALTH STORY


340 At the time that the ban was introduced, it was thought that all that the
Regulations needed to do was to prevent the deliberate inclusion of ruminant protein
in cattle feed. The Regulations were not designed to make unlawful the accidental
contamination of cattle feed with small quantities of feed containing ruminant
protein. Nor did they confer adequate powers of entry, inspection of records and
sampling.

341 For the same reason, the development of a test to detect the presence of small
amounts of ruminant protein in cattle feed was not treated as a matter of high
priority. Five years were to elapse before the ELISA test was developed to a point
at which some practical use could be made of it.

342 These shortcomings were symptomatic of a lack of rigorous thought about the
implementation of the ruminant feed ban and the risk of cross-contamination at the
time that it was introduced, which we have discussed in Chapter 3 above.

343 The risk of cross-contamination was then masked by the introduction of the
animal SBO ban. We believe that it was because of the second line of protection
apparently afforded by this ban that the Lamming Committee had no concerns about
the possibility of contamination of ruminant feed. The Committee expressed
concerns about the lack of control of on-farm mixing, but not in the context of BSE.

344 No sense of urgency attended the introduction of the ruminant feed ban. This
was because of a fundamental misunderstanding of the scale of infection that was
taking place. It was believed that infection had probably been occurring at a uniform
rate of perhaps no more than 60 cases a month. In fact, the latent snowballing effect
of recycling had boosted the rate of infection to 10,000 cases a month or more.45 No
one is to be criticised for failure to appreciate the scale of the problem. We do,
however, censure (although we do not have the means to identify) those in the feed
industry who deliberately breached the ruminant feed ban by continuing to supply
ruminant feed that contained animal protein after 18 July 1988, when the ban came
into force.

345 For some years MAFF officials proceeded on the basis that all necessary steps
had been taken to eradicate BSE. As Mr Thomas Eddy46 was to remark to
Mr Waldegrave in February 1995, the long incubation period meant that five years
had to elapse before it could become apparent whether precautionary arrangements
and compliance by the industry were adequate. As the numbers of BABs increased,
and their dates of birth grew later and later, MAFF officials progressively extended
the period of carry-over of cattle feed containing ruminant protein that they assumed
must have occurred. To an extent they were correct and we do not feel that they can
be criticised for not appreciating until 1994 that a significant cause of infection of
BABs was cross-contamination of cattle feed.

346 At that stage there were a number of alternative options to address the
problem. The most radical was to prohibit the use of MBM in all animal feed. As
Mr Meldrum remarked to Mr Hogg, the economic consequences of this would be
‘devastating’ and a serious waste disposal problem would be created. In the absence
of evidence that BSE was transmissible to humans, we do not consider that this
extreme measure was called for. To have adopted it, simply to prevent cross-
45
     We base this figure on the rate of confirmation of cases five years later, assuming that for every cow that developed clinical
     signs there would have been several infected cattle slaughtered before signs developed
46
     Head of Animal Health (Disease Control) Division, MAFF                                                                           67
FINDINGS AND CONCLUSIONS


         contamination of feed in feedmills and on farms, would have been an admission of
         defeat. Other, less drastic, viable options were open.

         347 At one time we were attracted by the view that feedmills should have been
         required to process feed for ruminants and feed for non-ruminants in separate
         production lines. We were, however, persuaded that to have insisted on the heavy
         expenditure necessary to achieve this would also have been disproportionate.
         MAFF’s approach was to concentrate on procuring proper implementation of the
         SBO ban. This included requiring renderers to process SBO in dedicated plant. We
         consider that it was reasonable for MAFF officials and Ministers to conclude that it
         was not necessary to require feedmills to undertake, in parallel with renderers, the
         expense of installing duplicate lines. Instead MAFF sought to encourage feedmills
         to take voluntary steps to reduce the potential for cross-contamination.

         348 With hindsight, we can deduce that the measures that MAFF had already taken
         had had a dramatic cumulative effect in reducing infection year on year. Looking
         back five years from end-June 2000, we see only 232 BABs which were born in
         1995, and only 2 born in 1996. But for the events of March 1996 MBM would have
         remained part of the diet of pigs and poultry and MAFF would have been able to
         claim that, by a combination of the ruminant feed ban and the animal SBO ban, they
         had virtually eradicated infection of cattle with BSE.

         349 It is this consideration which has led us, at the end of the day, to conclude that
         no criticism need be made of the somewhat muted attempts by both MAFF officials
         and UKASTA to get feedmills and farmers to take steps to tackle cross-
         contamination. When it was appreciated that this was occurring, and that a quantity
         as small as 1 gram of infective material would suffice to transmit the disease orally,
         one might have expected UKASTA urgently to draw these facts to the attention of
         its members and MAFF to do the same in relation to cattle farmers and to feedmills
         that were not members of UKASTA.

         350 We suspect that the more measured approach that was adopted was explained
         by a shared reluctance on the part of MAFF and UKASTA to adopt a course that
         might lead to feed compounders ceasing to use animal protein as a feed ingredient.
         For the reasons that we have given, we do not feel that this was an unreasonable
         attitude to adopt.



         Introduction of the animal SBO ban

         351 In Chapter 4 we examined the consideration given by the Southwood Working
         Party to the risk that attached to eating beef or offal from animals infected with BSE
         but not yet showing clinical signs (subclinical animals). We saw that the Working
         Party did not consider that the risk posed to humans (other than babies) justified any
         precautions. The same was true in relation to the risk involved in feeding such
         matter to animals, although the Working Party expressed some general reservations
         about the practice of disposing of animal waste in this way.

         352 As we have pointed out, the virulence of the infectivity of subclinical animals
         is indicated by the fact that, despite the ruminant feed ban and the animal SBO ban,
68       over 41,000 cattle born after 18 July 1988 developed clinical signs of BSE. Most of
                                                                   THE ANIMAL HEALTH STORY


these would have been infected by MBM derived from apparently healthy cattle,
since clinically affected animals were removed from the human and animal food
chains.

353 In June 1989 the Government announced that it had decided to go beyond the
precautions recommended by the Southwood Working Party and to ban Specified
Bovine Offal (SBO) from human food.47 MAFF officials had reservations about
imposing the human SBO ban. These included apprehension that it might lead to
public pressure for further precautionary measures. These concerns were soon to
prove well founded.

354 Even before the human SBO ban was introduced, the pet food industry had
been considering whether to stop incorporating in pet food those bovine tissues
most likely to be infectious if they came from an animal incubating BSE. The major
pet food manufacturers have a guiding principle, which is that nothing should be
incorporated in pet food which is not fit for human consumption. No sooner had the
Government announced that it intended to introduce a ban on including certain
types of bovine offal in human food than the Pet Food Manufacturers’ Association
advised its members to exclude this offal from their products.

The voluntary animal SBO ban

355 At this time farmers began to express concern about purchasing pig and
poultry feed that contained animal protein – particularly protein derived from
those parts of cattle which had been banned from human consumption. Some
supermarkets were also showing a reluctance to purchase meat from animals that
had been reared on such feed. In order to restore customer confidence UKASTA
decided in July 1989 to advise its members to insist that any MBM which they
purchased for incorporation in animal feed should be SBO-free. This led the UK
Renderers’ Association (UKRA) to threaten that its members would be forced to
refuse to accept SBO for rendering if there ceased to be any custom for the end
product. Mr Meldrum persuaded UKASTA to defer introducing its voluntary ban
until the human SBO ban came into force.48

356 It was at this time that Mr Gummer succeeded Mr MacGregor as Minister
of Agriculture. In September he received a submission from his officials about
UKASTA’s proposed voluntary ban. They had considered, in the light of the
Southwood Report, whether any restrictions should be placed on feeding animal
protein to non-ruminants and decided that there was no scientific justification for
this. In their submission to Mr Gummer, they warned of ‘serious implications’ if
UKASTA went ahead with its proposed ban. Renderers would be likely to refuse to
accept 1,500 tonnes of SBO per week. Slaughterhouses left with SBO on their hands
might be forced to close. Public pressure might grow for a complete ban on animal
protein in animal feed.

357 At a meeting with UKASTA on 2 October 1989, Mr Gummer sought to
dissuade the Association from its proposed ban, arguing that there was no scientific
justification for this. He said that the human SBO ban was only being introduced for
‘administrative convenience’.49 UKASTA remained unmoved by this and by
47
     See Chapter 6 below
48
     This proved to be 13 November 1989
49
     See paras 564ff as to the basis for this statement                                69
FINDINGS AND CONCLUSIONS


         continued pressure from MAFF officials to drop its ban. Later in the month
         Mr Lawrence wrote:

                Despite all our efforts UKASTA seem hell bent on pursuing their potentially
                damaging course . . . I am concerned and aggrieved that UKASTA seem
                blind to the consequences of their actions.

         358 On 9 November, four days before the human SBO ban came into force,
         UKASTA issued a circular to its members recommending that their contracts for the
         purchase of MBM should stipulate that this must be SBO-free.

         359 Not all feed compounders refused to accept MBM derived from SBO. A
         limited market developed for this, at a lower price than SBO-free meal. Renderers
         sought to satisfy the demands of those customers seeking meal that was free of SBO
         by insisting that slaughterhouses separate the SBO from other offal. Renderers
         collected the SBO in separate containers for processing as waste, but charged for
         doing so. Renderers had, however, no means of ensuring that slaughterhouses
         complied strictly with this requirement. MAFF officials continued to protest that
         there was no justification for the ban.

         360 In introducing a voluntary SBO ban, UKASTA and UKRA were doing no
         more than responding to customer demand. They were not concerned with the
         question whether or not their customers’ perceptions were scientifically sound; or
         with the adverse financial consequences that the ban had for slaughterhouses. These
         were matters of legitimate concern to MAFF. There were good grounds for
         believing that pigs and poultry had shown themselves impervious to TSEs – a point
         on which Mr Meldrum sought and obtained confirmation from Professor
         Southwood. We have no criticism to make of MAFF officials’ and Ministers’
         vigorous opposition to the voluntary SBO ban at this stage of the story.

         361 In the months that followed, MAFF came under increasing pressure to
         introduce a statutory ban on the incorporation of SBO in animal feed, and some
         pressure to introduce a total ban on feeding animal protein to animals. Ministers
         sought reassurance that there was no merit in these proposals. Their officials
         assured them that they had no scientific justification. This reassurance Mr Gummer
         conveyed to the Prime Minister, Mrs Margaret Thatcher, at the end of January 1990,
         when she in her turn queried whether it was desirable to continue feeding animal
         protein to pigs and poultry. Over the months that followed, MAFF officials
         continued to insist that there was no scientific justification for an animal SBO ban.
         Then came the cat.

         The cat

         362 On 9 May 1990 Mr Gummer was informed that a Siamese cat had died of a
         spongiform encephalopathy. This was the first known case of Feline Spongiform
         Encephalopathy (FSE). The public reaction was predictable. Had the cat caught
         BSE? If BSE could be transmitted to a cat, why not to humans? The media had a
         field day. We deal with the human health implications of the cat later. Here we are
         concerned with the implications it had in relation to animal feed.

70
                                                                     THE ANIMAL HEALTH STORY


363 It was not clear at the time whether there was any connection between BSE
and the cat. It was possible that cases of FSE had occurred in the past, but had never
been diagnosed. Mr Gummer understood from Mr Meldrum that there was no likely
connection between the cat and BSE. Mr Meldrum should not have given this
reassurance, for it put the matter too high.

364 The cat led to renewed public concern about the practice of feeding SBO to
pigs and poultry. In a meeting with Mr Gummer, Sir Simon Gourlay, the President
of the National Farmers’ Union (NFU), suggested that MAFF should introduce a
statutory SBO ban for pig and poultry feed, thereby regaining the initiative and
restoring public confidence. Mr Gummer’s response was that there was no scientific
justification for such action, which would be unlikely to allay public concern but
would merely move the debate to another vulnerable area. The NFU was not
convinced. In June 1990 it issued advice to farmers recommending that they should
not use animal feed that included SBO.

365 That there was no scientific justification for an SBO ban remained MAFF’s
public position. The cat had changed nothing. SEAC had, however, been asked to
give urgent consideration to the implications of the cat. SEAC then indicated that it
wanted to give consideration to pig and poultry feed. This led Mr Gummer, who
previously had seen no need to refer this matter to SEAC, to ask the Committee to
consider the whole question of feeding animal protein to animals. Neither he nor his
officials thought it appropriate to inform the feed industry or others that he had done
so. Mr Andrews, the Permanent Secretary, remarked that ‘the issue would have to
be very carefully handled’.

366 The issue was carefully handled. Over a period of several months a paper was
prepared for SEAC on the inclusion of SBO in feed for non-ruminants. This set out
MAFF’s reasons for concluding that there was no justification for preventing this
practice and invited SEAC to endorse that conclusion. In August 1990 the paper was
submitted to Mr Gummer for his approval, which it received. But before the paper
could be considered by SEAC, it was overtaken by events (see paragraph 368
below).

367 The furore that greeted the announcement of the first case of FSE led MAFF
to adopt an unnecessarily defensive approach to pressure for an animal SBO ban.
Public pronouncements suggesting that the cat was no cause for concern did not
carry conviction. MAFF witnesses emphasised to us that if any doubt had been
expressed, this would have been treated as being of major significance, indicating a
possible change of policy. We do not criticise MAFF officials for the cautious
stance that they took, but we feel that it was ill-judged in that it harmed their
credibility. They would have done better to state openly that, while MAFF did not
consider that the cat called for any change of policy, SEAC had nonetheless been
asked to advise whether it had any implications in relation to the composition of
animal feed.

The pig

368 In August 1990 the whole picture was changed by the experimental
transmission of BSE to a pig by injection of infectious material into the brain. This
experiment had started 15 months earlier. In July 1990, in a note to Mr Gummer,
                                                                                          71
FINDINGS AND CONCLUSIONS


         Mr David Maclean, the Minister for Food Safety, suggested that some contingency
         planning should be put in hand against the possibility that this experiment might
         produce a positive result. He expressed the view that in that event:

                   We would have no option but to ban specified offals from pig and poultry
                   feeds also. No-one should imagine that we could do anything else. It would
                   be pie in the sky to believe that we could hold the line on this or somehow
                   distinguish poultry feed from pig feed.

         369 MAFF officials did not agree. In a note to Mr Andrews, which he told us he
         had cleared with his veterinary colleagues, Mr Robert Lowson50 said that there was
         not much that they could do to prepare for the possibility that offal would have to
         be banned from pig and poultry feed, but that this would only become necessary if
         it was shown that transmission could be effected by the feed route. Transmission by
         inoculation would not justify a ban. Mr Andrews endorsed this view. It proved to be
         wrong.

         370 When, on 20 August, news was received that BSE had been transmitted
         experimentally to a pig, Mr Meldrum and Mr Gummer agreed that this should be
         kept confidential until SEAC’s advice had been obtained. An emergency meeting
         of SEAC was held on 7 September. A paper was prepared for this meeting by
         Mr Meldrum which put forward three options:

                   •     Do nothing
                   •     Ban MBM derived from SBO from animal feed
                   •     Ban all MBM from animal feed.
         The paper stated that the second option:

                   . . . would, in practice, simply add the weight of legislation to an arrangement
                   which is already operating de facto on a voluntary basis. This is the option
                   that holds most attraction for the Ministry’s veterinary advisers.

         371 By the time of SEAC’s meeting, FSE had been reported in nine cats. SEAC
         concluded that the result of the pig experiment indicated that it would be prudent to
         exclude SBO from pig diet, and that the cases of FSE suggested that a cautious view
         should be taken of those species which might be susceptible to BSE. Accordingly
         SBO should be excluded from the feed of all species. Mr Meldrum’s second option
         had found favour.

         The statutory animal SBO ban

         372 When Mr Gummer was informed of this advice, he accepted it. This accorded
         with an approach to BSE that he had decided to adopt as a matter of principle:
         decisions on what action should be taken in the face of any development should
         always be referred to SEAC, and SEAC’s advice should be followed.

         373 On this occasion Mr Gummer was determined that news of the result of the
         pig experiment should not leak out until MAFF was in a position to announce its
         response to it. The task of drafting appropriate Regulations was tackled by the
72       50
              Head of Animal Health Division, MAFF
                                                                         THE ANIMAL HEALTH STORY


MAFF lawyers based on instructions from officials in what had become the Animal
Health and Veterinary Group, but without any wider consultation. Although
implementation of an animal SBO ban would involve, as a matter of critical
importance, practices in the slaughterhouse, Mr Keith Baker, the Assistant Chief
Veterinary Officer responsible for meat hygiene, was not consulted. Instructions
were given that the Territorial Departments in Wales, Scotland and Northern Ireland
were to be informed ‘at the latest possible moment and in such a way that as few as
possible people were in the picture’.

374 SEAC confirmed its advice on 20 September. The draft Order implementing
it was submitted for signature on 21 September. MAFF announced the making of
the Order51 in a news release on 24 September and the Order came into force on the
following day. Mr John Maslin of the Animal Health Division was to describe the
Order as made ‘in haste and secrecy’. That was a fair description.

375 The new Order amended the Order that had introduced the ruminant feed ban.
It prohibited the sale, supply and use of SBO, feedstuffs containing SBO, or animal
protein derived from SBO for feeding to animals and poultry. It also prohibited the
export to EU Member States of feedstuffs containing SBO or animal protein derived
from SBO.



The operation of the statutory animal SBO ban

376 We noted earlier in this volume that the ruminant feed ban was not fully
effective. One reason was that ruminant feed was contaminated by feed for pigs and
poultry which contained bovine MBM from cattle incubating BSE. After September
1990, when the animal SBO ban came into force, this cross-contamination should
not have mattered. Pig and poultry feed should not have contained any MBM
derived from SBO. If a little of this got mixed with feed for cattle it should have
caused no harm. This was not the reason for bringing in the animal SBO ban, but it
should have been one of its effects.

377 The large number of BABs born after September 1990 shows that something
went very wrong. Over 12,000 of these animals developed signs of BSE. A much
greater number must have been infected with BSE, but were slaughtered and eaten
before any signs developed. How were all those cattle infected? For the vast
majority it was because their feed had been contaminated by pig and poultry feed
infected with BSE. How was it that, despite the animal SBO ban, BSE was getting
into pig and poultry feed? There is more than one answer. In Chapter 4 of vol 5:
Animal Health, 1989–96 we identify two reasons which probably played a minor
part:

     •    The Order excluded from animal feed the SBO that was banned from human
          consumption, but did not identify all the potentially infective tissues and
          products which might go into animal feed.
     •    SBO was not always cleanly removed from the parts of the carcass that went
          to be rendered for animal feed.


51
     The Bovine Spongiform Encephalopathy (No. 2) Amendment Order 1990                     73
FINDINGS AND CONCLUSIONS


         378 Each of these sources of potential infectivity is, we believe, of insignificance
         compared with the primary source of the infectivity that resulted in BABs. This was
         that SBO was mixed, both deliberately and by accident, with carcass remains that
         were rendered for animal feed.

         379 There were always going to be problems with enforcing the animal SBO ban.
         The financial temptation to pass off SBO as offal fit for incorporation in animal feed
         was considerable. There were ample opportunities, in the slaughterhouse, in the
         collection centres and at the renderers to give way to this temptation. Admixture
         of SBO with other offal was hard to detect. Those practical problems were
         compounded by the form of the Regulations that were put in place. They were, quite
         simply, unenforceable. To explain why this was, we shall have to lead the reader
         through a complex regulatory maze.

         Before the ban

         380 In order to understand the working of the animal SBO ban, it is necessary
         to appreciate the scheme that operated for dealing with meat unfit for human
         consumption, including SBO, before the ban was introduced. This is a topic of
         complexity, dealt with in detail in Chapter 4 of Volume 5. Here we shall give a
         greatly simplified account.

         381 Animals killed for human consumption had to be slaughtered in a licensed
         slaughterhouse. The parts of the animal which were not wanted or were not fit for
         human consumption would normally be removed to a renderer to produce tallow
         and MBM – the latter being used as an ingredient of animal feed.

         382 Fallen stock or animals put down on the farm would normally be collected by
         a knacker’s yard or hunt kennel. Although they could not be used for human food,
         a variety of other uses were made of these carcasses. Remnants, including heads and
         spinal columns, would commonly go to be rendered to produce tallow and MBM
         used for animal feed. This waste from knackers and hunt kennels provided about
         10 per cent of all rendered material.

         383 The Meat (Sterilisation and Staining) Regulations 1982 (MSSR) were
         complex provisions designed to ensure that unfit meat was not used for human food.
         In a slaughterhouse, Meat Inspectors had to identify unfit meat and ensure that it
         was separated from the meat that was to go for human consumption. They applied
         a health stamp on the meat that was going for human consumption. The unfit meat,
         if not sterilised on the premises, normally had to be stained black. It could only leave
         the slaughterhouse after the issue of a permit authorising its removal to an approved
         destination, which would normally be a renderer. A copy of the permit would have
         to accompany the unfit meat to its destination, before being returned to the local
         authority which had issued it, so that a check could be made that the unfit meat had
         not gone astray.

         384 At the knacker’s yard and hunt kennel, the MSSR provided that all meat had
         to be treated as unfit for human consumption. Any remnants sent off to be rendered
         had to be stained black and accompanied by a movement permit.

74
                                                                                                            THE ANIMAL HEALTH STORY


385 Limited exceptions were made to requirements to stain and to obtain
movement permits in respect of some categories of unfit meat when they were
placed in a container of green offal. Green offal consisted of the intestine and
stomach of the cow, together with their contents. Green offal was unfit for human
consumption and was readily identifiable, and so was not required to be stained. It
acted as a passport for the unfit material that it cloaked.

The human SBO Regulations

386 The human SBO Regulations52 followed the scheme of the MSSR. Their broad
effect was to add a parallel regime so that SBO had to be handled in a similar way
to unfit meat under the MSSR. The Regulations applied only to slaughterhouses, as
in knacker’s yards and hunt kennels the whole of the carcass was already treated as
unfit for humans and subject to the MSSR. SBO had to be stained in the same way
as other unfit meat, stored separately from meat fit for human consumption and
removed under cover of a movement permit. But there was no requirement that SBO
should be kept separate from other unfit meat. On the contrary, the Regulations
permitted SBO to go down the same chute as other unfit meat into the same
container to be stained by a common stain and removed to the renderers as a single
consignment.

387 There were one or two complications. Bovine intestine was an SBO. Under
the 1982 MSSR, intestine and its contents, being a constituent of green offal, did not
have to be stained even if found unfit for human consumption. Like other green
offal, it could act as a passport for unfit meat in the same container, but that was not
the case under the human SBO Regulations, under which bovine intestines were
subject to the requirements of staining and movement permits. Nor did the
Regulations explain how the system of movement permits should operate in respect
of a mixed consignment of SBO and other unfit meat.

Enforcement

388 Regulations made under the Food Act 1984 and its successor the Food Safety
Act 1990 fell to be enforced by the District Councils, of which there were 275, and
by the unitary authorities in the Metropolitan and London Boroughs.53 Thus the
1982 MSSR and the human SBO Regulations fell to be enforced by this tier of local
authorities, which were also responsible for enforcing the Meat Inspection and Meat
Hygiene Regulations in slaughterhouses. Their Environmental Health Departments
employed Authorised Meat Inspectors (AMIs) and Environmental Health Officers
(EHOs), who were trained in meat inspection, to enforce all these Regulations.
Some slaughterhouses were approved to produce meat for export. In these, Official
Veterinary Surgeons (OVSs) engaged by the local authorities were responsible for
overseeing the implementation of all hygiene and meat inspection Regulations. This
became the rule in all slaughterhouses – domestic and export – following the
introduction of the European Single Market on 1 January 1993.

389 Hygiene standards varied enormously in British slaughterhouses from the
lamentable to the good, with the majority tending towards the former rather than the
52
     The Bovine Offal (Prohibition) Regulations 1989
53
     Slightly different arrangements applied in Scotland, though again the main task fell to local authorities, and in Northern Ireland,
     where the State Veterinary Service was directly involved. For simplicity we focus here on England and Wales, but the features
     and failings we describe apply elsewhere                                                                                              75
FINDINGS AND CONCLUSIONS


         latter. This meant that the United Kingdom was unable to satisfy European
         standards and led, in 1995, to the transfer of meat hygiene enforcement functions in
         slaughterhouses from local authorities to central government, and to the
         establishment of a national Meat Hygiene Service, responsible to MAFF, to carry
         out those functions. Until that occurred there was a wide disparity, not merely in
         hygiene standards, but in the manner in which, and rigour with which, individual
         local authorities organised the fulfilment of their slaughterhouse enforcement
         obligations. In many slaughterhouses, staffing levels were such that Meat
         Inspectors had little time for anything except the vital function of ensuring that unfit
         meat did not go for human consumption. This was one reason why hygiene
         standards were so poor.

         390 The MSSR 1982 were designed to ensure that unfit meat was not diverted into
         the human food chain. By 1989 in most slaughterhouses a routine had become well
         established under which the unfit material would be regularly collected by a local
         renderer to be turned into tallow and MBM for animal feed. Some was supposed to
         be stained and removed under a movement permit. Some travelled cloaked in green
         offal. Where such a routine was established, local authorities were permitted to
         authorise slaughterhouses to make out their own movement permits, and did so. In
         such circumstances, the Meat Inspectors and EHOs in many slaughterhouses
         devoted little time or effort to enforcing what seemed no more than formalities of
         movement permits and requirements as to staining and carrying unfit material in
         sealed and marked containers.

         391 Once the container of offal left the slaughterhouse for the renderer, all
         supervision ceased. Often the container did not go direct to the renderer. Lorries
         would collect containers from a number of slaughterhouses, and sometimes they
         would be taken to collection centres, where offal from different slaughterhouses
         would be combined into larger consignments for onward carriage to the renderer.
         The MSSR 1982 envisaged that checks would be made on containers of unfit meat
         when in transit. So far as we are aware no such checks were ever made. The only
         checks carried out by District Councils were the reconciliation of movement
         permits once these were ultimately returned from the renderers, and the evidence
         was that this formality was, in practice, not an effective check.

         392 If Meat Inspectors and EHOs had little time for enforcement of what may have
         seemed over-bureaucratic Regulations, the Government’s deregulation initiative
         tended to convey, whether rightly or wrongly, the message that it was not desirable
         to be over-fastidious in insisting on compliance with the letter of the Regulations
         when there was no concern of substance that their object was not being achieved.

         393 The evidence that has led us to these conclusions is set out in detail in Volumes
         5 and 6. Some of it came to light when Mr Lawrence of MAFF was leading a team
         to investigate how enforcement of the Regulations worked in practice as part of the
         task of introducing the Meat Hygiene Service. Some of it came to light in 1994 and
         1995, when very significant shortfalls were discovered in the quantities of SBO that
         were going for rendering. Some represents the testimony of individual witnesses
         given to the Inquiry.

         394 One piece of evidence, which we found particularly significant, merits specific
         mention here. When the human SBO ban was introduced, it focused the attention of
76       the Environmental Health Departments of the local authorities on the practical
                                                                     THE ANIMAL HEALTH STORY


problems of the scheme established under the MSSR 1982. On 1 February 1990
Mr Mike Corbally of the Institution of Environmental Health Officers wrote to the
Animal Health Division of MAFF with no less than 11 pages of enquiries and
comments about the human SBO ban that the Institution had received. In particular,
the requirements of the Regulations as to the containers in which unfit material was
stored and transported and the formalities in relation to movement permits were
proving difficult or impossible to comply with in practice. In 1994 MAFF was again
to receive information that the system of movement permits was not working and
‘had to rely on trust’.

The voluntary animal SBO ban

395 The MSSR and human SBO Regulations provided two parallel systems for
handling all unfit meat. Renderers and the animal feed industry lost little time in
introducing a practice of greater complexity. Under the voluntary animal SBO ban,
described earlier in this chapter, feed merchants required renderers to supply MBM
free of SBO, for incorporation into animal feed. The renderers, in their turn,
required the slaughterhouses to segregate SBO from other offal. Other offal the
renderers would pay for, as the raw material of MBM which they could sell on. SBO
was unwanted waste. The renderers made a substantial charge for disposing of this.

396 The voluntary animal SBO ban was not complied with by all. Renderers found
a market, albeit diminishing, of feed compounders who were happy to purchase, at
a reduced price, MBM derived from SBO. Nor was there confidence that those who
were purporting to comply with the voluntary ban were being scrupulous in doing
so. It was difficult, if not impossible, to tell whether a container of decomposing
offal contained an element of SBO. The financial temptation for slaughterhouses
to pass off SBO as non-SBO material was considerable. Forced to trust the
slaughterhouses, but with reservations about doing so, the renderers contracted with
the feed merchants, not that they would supply MBM that was SBO-free, but that
they would do their best to do so. Renderers, also, were under a temptation not to
look too closely at the material that they were rendering to sell at a profit lest they
should have to treat it as SBO to be disposed of at cost to themselves.

397 This, then, was the regime prevailing when the animal SBO ban was
introduced.

The statutory animal SBO ban

398 The provisions in the Order bringing in the animal SBO ban were very short
and simple. They made it an offence knowingly to sell or supply for feeding to
animals or poultry, or to feed to any animals or poultry, any SBO. The same applied
to any animal feedstuff known to contain SBO or where there was reason to suspect
this. There was a fundamental problem with these provisions. Neither the feed
compounder nor the farmer had any means of knowing whether animal protein
incorporated in the feed had been derived from SBO. They were reliant on renderers
to ensure that the MBM that they supplied was not derived from SBO. But the Order
did not expressly make it an offence for renderers to manufacture MBM from SBO.
It was arguable whether, on a proper construction of the Order, supplying such
MBM to feed compounders was an offence. The renderer in his turn relied on the
                                                                                          77
FINDINGS AND CONCLUSIONS


         slaughterhouse, the knacker’s yard and the hunt kennel to ensure that material
         supplied was separated into SBO and other offal. Yet the Order did not require this.

         399 If those whose duty it was to comply with the animal SBO ban had no means
         of knowing whether ruminant protein incorporated into animal feed was derived
         from SBO, those responsible for enforcing the ban were in an even worse position.
         They had no means of proving that animal feed contained protein derived from
         SBO, let alone that those supplying the feed, or feeding it to animals, knew that it
         contained SBO. The Order was unenforceable.

         400 In England and Wales, enforcement of Orders made under the Animal Health
         Act 1981 was the statutory responsibility of the County Councils and the Unitary
         Authorities in the Metropolitan and London Boroughs. Thus outside the
         Metropolitan and London Boroughs it was not the District Councils (responsible for
         the human SBO ban) but the County Councils that were responsible for the
         enforcement of the animal SBO ban. The County Councils sought to discharge that
         responsibility through the Trading Standards Officers employed by their Trading
         Standards Departments.

         401 We had little evidence to suggest that Trading Standards Officers made any
         attempt to enforce the animal SBO ban, which is hardly surprising having regard to
         the practical problems of enforcement that we have described above. We did receive
         evidence of consideration being given by the Trading Standards Officers of one
         county, in conjunction with the State Veterinary Service and the local District
         Council, to taking action to address the practices of a particular renderer who
         allowed SBO to become mixed with offal that was going to be rendered to produce
         MBM for sale to feed compounders. It was concluded that there was no action that
         could be taken because:

                    i.     There was no provision in the animal SBO Regulations which made it
                           an offence for a renderer to mix SBO material with non-SBO material.
                    ii.    It was impossible to demonstrate that MBM which was being sold for
                           incorporation into animal feed was derived in part from SBO materials.

         402 Much later, in 1995, after defects in the Regulations had been identified, new
         provisions were introduced which were enforceable.54 They included the following
         requirements:

              •     On removal from the carcass, whether in the slaughterhouse, the knacker’s
                    yard or elsewhere, SBO had to be kept separate from all other material.
              •     SBO had to be dyed with a distinctive blue stain.
              •     SBO had to be removed to approved premises for disposal.
              •     SBO had to be kept separate from all other material at all stages of its
                    progress from the slaughterhouse to final disposal.
              •     Records had to be kept of receipt and onward despatch of SBO at each stage
                    of its journey from the slaughterhouse to final disposal.



78       54
              The Specified Bovine Offal Order 1995
                                                                       THE ANIMAL HEALTH STORY


403 Why were the shortcomings in the animal SBO Regulations not identified at
the time that those Regulations were introduced? Why did the Regulations not
include requirements such as those introduced in 1995? Broadly, witnesses from
MAFF gave two answers to these questions:

          i.     The Regulations were merely giving statutory force to the animal SBO
                 ban that was already in place on a voluntary basis. This ban was being
                 taken seriously and appeared to be operating satisfactorily.
          ii.    A detailed statutory code for the handling of SBO already existed under
                 the human SBO ban. Enforcement of this ban would have the additional
                 benefit of ensuring that the animal SBO ban was complied with.

404 These views were implicit in this observation made by Mr Maslin in his
submission inviting Mr Gummer to approve the draft Order:

          Enforcement is the responsibility of the Local Authorities. They are already
          monitoring and enforcing the Bovine Offal (Prohibition) Regulations 1989.
          In practice, the specified offal is being separated from other material at the
          abattoir. It is collected and processed separately by renderers. As with the
          existing ruminant feed prohibition, the ban on its sale, supply and feeding
          will, to a large extent, be self-policing. In these circumstances there would
          be little or no resource implications for Local Authorities.55

Reliance on the voluntary animal SBO ban

405 We have already drawn attention to the fact that the voluntary animal SBO
ban was not universally applied. We have also drawn attention to the financial
consequences of that ban, the motive that these gave for evasion and the doubts as
to compliance – particularly in relation to the slaughterhouses. On the evidence that
we received, there were no reasonable grounds for concluding that there was or
would be satisfactory compliance with the animal SBO ban on a ‘self-policing’
basis. The voluntary animal SBO ban was not a satisfactory alternative to a statutory
scheme that was capable of enforcement. We identify below the MAFF officials
who should have appreciated this.

Reliance on the human SBO ban

406 Reliance on enforcement of the human SBO ban as a means of enforcing the
animal SBO ban was misplaced for a number of reasons:

     •    For the reasons given above, Meat Inspectors, EHOs and OVSs were
          unlikely to devote much energy to enforcement of the technical requirements
          of staining and movement permits under the MSSR and the human SBO
          Regulations.
     •    Strict compliance with those Regulations was not practical and was not
          being insisted upon, as Mr Corbally’s letter had demonstrated.
     •    It was of critical importance from the viewpoint of the animal SBO ban that
          SBO should be kept separate in the slaughterhouse and not mixed, whether
55
     YB90/09.21/14.3                                                                       79
FINDINGS AND CONCLUSIONS


                   by accident or design, with carcass remains that were going to be supplied to
                   renderers as fit for incorporation in animal feed. There was, however, no
                   statutory requirement in the human SBO Regulations that such separation
                   should take place. There was thus no relevant Regulation for the District
                   Council officials to enforce.
              •    Witnesses suggested that the AMIs and the EHOs employed by the District
                   Councils would have been ready to help out their colleagues on the County
                   Councils by ensuring that SBO was in fact handled separately from other
                   unfit material. Although we have no doubt that many District Councils and
                   County Councils cooperate closely, we were not persuaded that District
                   Council officials, whose responsibilities were to protect human health,
                   would be enthusiastic about enforcing practices that had relevance only to
                   animal health, the more so when those practices were not required by any
                   Regulations. In 1994 a MAFF official was to report of the District Councils:

                   It is clear that some Local Authorities see the legislation merely as an
                   exercise in removal of SBO from carcasses and preventing its use for human
                   foodstuffs.

                   We did not find that attitude surprising. It reflected precisely the area of
                   legitimate concern for District Council officials.

              •    If the two tiers of councils were to cooperate in trying to make the animal
                   SBO ban work, it was desirable that they should have been given some
                   guidance by MAFF officials as to what was expected of them. No such
                   guidance was given. They were simply sent a copy of the 1990 Order and
                   asked to arrange a meeting if they wished to discuss its enforcement. No such
                   request was received.

         Knacker’s yards and hunt kennels

         407 So far we have been concentrating on slaughterhouses, for they were the major
         suppliers of raw material to the renderers. Turning to knacker’s yards and hunt
         kennels, we find a particularly unsatisfactory state of affairs.

         408 The definition of SBO in the animal SBO Order followed that of the human
         SBO Regulations. This defined SBO by reference to offal from animals
         ‘slaughtered’ in the UK. The ban thus did not apply to any offal from fallen stock –
         the major source of knacker meat. It is not clear to what extent knacker’s yards and
         hunt kennels took advantage of this lacuna and continued to use SBO as a source of
         animal feed, for MAFF made it plain that the Order was intended to apply to these
         premises. This error in the Order was remedied by amendment in 1991.56

         409 Although the 1991 amendment of the animal SBO Order made it illegal to feed
         to animals SBO from fallen stock, or protein derived from this, there were no
         Regulations which required a renderer to separate SBO from other material. The
         handling of knacker meat was governed by the MSSR 1982, which treated all of it
         as unfit for human consumption. There was no statutory basis for insisting that
         knacker’s yards or hunt kennels separate SBO from other material being sent to
         renderers. We are not aware of either County Councils or District Councils making
80       56
              By the Bovine Spongiform Encephalopathy Order 1991
                                                                   THE ANIMAL HEALTH STORY


any attempts to enforce the separation of SBO from other matter at knacker’s yards
or hunt kennels. Those renderers that were prepared to receive material from
knackers for production of MBM – and they were a minority – insisted that it should
be SBO-free. We are sceptical as to how rigorously the knacker’s yards complied
with that requirement.

SBO in transit

410 No Regulations required SBO to be kept separate from other offal when in
transit to the renderers. There was scope for admixture, deliberate or accidental,
when containers of SBO and non-SBO material were carried together on the back
of the same vehicle and, more particularly, when stored together in collection
centres. Neither District Councils nor County Councils considered it any part of
their duties to check what was happening to SBO in transit.



Responsibility

411 We turn to the question of who should bear responsibility for the shortcomings
in the animal SBO Order. Part of the problem was that the Regulations were
introduced ‘in haste and secrecy’ and without consultation. Had there been
consultation with those who would have to enforce the Order or those who were
knowledgeable about problems in slaughterhouses – and we have particularly in
mind Mr Keith Baker, the Assistant Chief Veterinary Office (ACVO), Meat
Hygiene – mistakes might have been avoided.

412 Are Mr Meldrum and Mr Gummer to be criticised for their decision to keep
the transmission to a pig and the measures being planned in response to it ‘under
wraps’? We do not think so. They were reacting to the furore that had been
generated when the news of FSE in a cat was announced before MAFF had been
advised by SEAC on its implications and whether any action was called for. With
hindsight, however, we believe that it would have been better if MAFF had
published SEAC’s advice of 7 September and stated that the voluntary ban that was
in place would be replaced with a mandatory ban after consultation. The fact that
the voluntary ban was already in place, albeit that it was not universally observed,
meant that MAFF could have justified taking a reasonable length of time to prepare
the Regulations for a compulsory ban.

413 The fact that the ban was introduced in haste need not have prevented those
who were responsible for its terms from giving rigorous thought to the question of
how it was to work. We have not found it easy to identify the parts played by
individual team members responsible for the Order, for instructions were given by
telephone and memories are hazy as to precisely what took place. Those involved
included Mr Maslin, Mr Lawrence, Mr Lowson and Mrs Elizabeth Attridge on the
administrative side, Dr Danny Matthews, Mr Kevin Taylor and Mr Meldrum on the
veterinary side, and Miss Gillian Richmond and Mr Ayyildiz Yavash from MAFF’s
Legal Department.

414 We do not consider that the lawyers are to be criticised for the contents of the
Order. It was primarily for those instructing them to consider how the Order would
                                                                                       81
FINDINGS AND CONCLUSIONS


         work in practice. Furthermore, we note that Miss Richmond ‘flagged up’ a warning
         that officials might be criticised for including provisions which were
         unenforceable.57

         415 We have concluded that, as head of the Animal Health Division, although he
         delegated the detailed discussions about the Regulations, Mr Lowson had ultimate
         responsibility on the administrative side of the team for ensuring that the terms of
         the Order were satisfactory. Mr Meldrum had lead responsibility for providing
         veterinary advice on the practicalities of the Order.

         416 We do not consider that either Mr Lowson or Mr Meldrum gave rigorous
         consideration to the requirements of the animal SBO ban. They should have
         appreciated that the working of the voluntary animal SBO ban did not demonstrate
         that there would be satisfactory compliance with the statutory animal SBO ban on
         a ‘self-policing’ basis. And they should have appreciated that in the form in which
         the Order was drafted, it was obviously unenforceable. We do not say that they
         should have identified all the answers to the considerable problems posed by the
         ban. They should, however, have identified that the problems existed.

         417 We would exclude from this criticism the lacuna in relation to fallen stock.
         This drafting error was not an obvious one, though it was quickly picked up. It was
         the kind of drafting point which can slip through the net when Regulations are
         drafted under pressure, and not one that we would necessarily have expected either
         Mr Lowson or Mr Meldrum to identify.

         418 We have drawn attention to the fact that the Regulations did not require SBO
         to be kept separate or treated differently from other unfit material in slaughterhouses
         or elsewhere, although such separation was required under the contractual
         arrangements between slaughterhouses and renderers. We are satisfied that this
         separation requirement was not properly implemented and that, both by accident
         and by design, substantial quantities of SBO were supplied by slaughterhouses to
         renderers as material that was fit to be rendered for animal feed. Although the
         State Veterinary Service undertook the task of monitoring performance of the
         Regulations, four or five years were to pass before MAFF discovered that the ban
         was not being properly implemented. We turn to examine this part of the story.



         Monitoring

         419 Ministers looked to the State Veterinary Service (SVS) to monitor and alert
         them to any problems arising over the enforcement by local authorities of
         Regulations introduced by MAFF. The Food Act 1984 gave MAFF’s veterinary
         inspectors the right to enter premises for this purpose. In 1989 Veterinary Officers
         (VOs) of the Veterinary Field Service (VFS) would make an annual visit to
         domestic slaughterhouses and a monthly visit to export-approved slaughterhouses
         to check that the various Regulations introduced by MAFF were being observed.
         These included the Meat Hygiene Regulations, the Meat Inspection Regulations,
         the MSSR and, after their introduction, the human SBO Regulations. Visits were
         also made by VOs to knacker’s yards on an annual basis to check on observation of
         Regulations which applied there.
82       57
              YB90/9.00/7.1
                                                                    THE ANIMAL HEALTH STORY


420 Reports of visits had to be submitted to MAFF on a prescribed Meat Hygiene
Inspection (MH1) form, which had space for entries in respect of each of the
applicable Regulations. When the 1990 Food Safety Act replaced the Food Act
1984, the right of entry of MAFF inspectors was not preserved. This did not inhibit
them from making their regular visits. They would normally, however, arrange to
visit in the company of the district council EHO responsible for supervising the
enforcement of the Regulations in the slaughterhouse in question.

421 The Animal Health Act 1981 gave MAFF’s veterinary inspectors the right to
enter premises on suspicion that the Regulations under that Act were not being
complied with. They also made regular visits to renderers to check for the presence
of salmonella in accordance with the Protein Processing Order of 1981.

422 If VOs found that Regulations were not being complied with, it was their duty
to inform the relevant local authority of this, giving guidance where necessary. The
breach would be recorded on the MH1 form and would thus be drawn to the
attention of MAFF officials at headquarters.

423 When the human SBO ban was introduced in November 1989, no specific
instructions were given to the VFS as to monitoring compliance with its
requirements. The human SBO Regulations were simply added to the list of those
that had to be checked on the MH1 form. Nor, initially, were any special steps taken
to monitor compliance with the animal SBO ban upon its introduction in September
1990. In October 1990, however, Mr Andrews, the MAFF Permanent Secretary,
suggested that the Ministry should carry out checks at slaughterhouses and
renderers so that Ministers could be assured that no SBO was getting into animal
feed. Mr Meldrum was quick to take up the suggestion. He asked Mr Keith Baker
to make arrangements for VOs of the Field Service to make special visits to
slaughterhouses and to renderers to check on the handling of SBO. Mr Baker was
the ACVO at the head of the Meat Hygiene Veterinary Section. It was strange, on
the face of it, that he should be charged with the checking of an animal health
measure. We would have expected this duty to fall to Mr Kevin Taylor, who was at
the time head of the Notifiable Diseases Section and subsequently became ACVO
responsible for animal health and welfare. The explanation was that the only
Regulations that made express provision for the handling of SBO were the human
SBO Regulations, and monitoring of these fell logically within the province of the
VOs with special training in meat hygiene.

424 The system that was set up required the Divisional Veterinary Officers to
submit monthly returns of visits made by the VOs in their divisions. These were
collated on a regional basis and sent to an officer of the Meat Hygiene Veterinary
Section at Tolworth – initially Mr Stephen Hutchins, followed in 1991 by Mr Alick
Simmons, who was himself succeeded in 1995 by Mr Andrew Fleetwood (an officer
in the Notifiable Diseases Section). That official prepared a summary giving the
national picture. Although Mr Baker set up this system, he told us that responsibility
for it subsequently shifted to Mr Iain Crawford, as head of the VFS; thereafter he
continued to receive the summaries of the returns, but only as ‘a matter of
politeness’ because they were prepared by one of his staff. Mr Crawford told us that
he had responsibility for advising on the practical problems of implementing policy
in the field, but no responsibility for making policy decisions or advising Ministers
on policy.
                                                                                         83
FINDINGS AND CONCLUSIONS


         425 Mrs Attridge, head of the Animal Health and Veterinary Group, explained to
         us that while administrators in her group had responsibility for monitoring and
         keeping the Regulations in relation to the animal SBO ban under review, her ‘eyes
         and ears’ on the ground were the field vets.

         426 We found this a confusing picture. No one person appears to have been
         responsible for keeping the adequacy of the monitoring of the animal SBO ban
         under review. As the story progressed the initiatives for tightening the system
         tended to come from Mr Meldrum.

         Renderers

         427 Initial returns on visits to renderers in January 1991 led Mr Meldrum to direct
         that there should be a further round of visits the following month and that thereafter
         renderers should be visited every two months. These early returns indicated that
         SBO was being kept separate from other material and that renderers were making
         sure that it did not get mixed with the material being processed for animal feed.
         Unofficial reports were nonetheless received by MAFF of wrongdoing in some
         rendering plants. As Mr Lawrence remarked, ‘short of catching them in the act it is
         a pretty hopeless task’.

         428 The reports disclosed one area of particular concern. Renderers used common
         plant for processing offal which produced MBM for incorporation in animal feed,
         and for processing SBO, whose product had to be kept out of animal feed and
         disposed of as waste. Methods of cleaning or purging the production plant between
         one batch and the next varied widely, with some plants doing nothing at all. Once
         again Mr Meldrum intervened. In September 1991 he asked Mr Simmons to draw
         up procedures which would ensure that no cross-contamination occurred at
         rendering plants. In consultation with UKRA, Mr Simmons prepared a ‘Code of
         Practice for the Handling of SBO at Rendering Plants’, which was distributed in
         August 1992. This provided for precautions to prevent ‘comminglement’ of SBO
         with other material. MAFF officials had expressed concern at the use of the
         description ‘cross-contamination’. The precautions included cleansing or purging
         of plants between batches.

         429 Had it been appreciated when the animal SBO ban was introduced that a very
         small quantity of infective material might suffice to transmit BSE orally,58 we have
         no doubt that more urgent steps would have been taken to address the risk of cross-
         contamination in the course of rendering. As it was, the Code of Practice was a
         significant, if tardy, step in the right direction. But as we shall see, events in 1994
         were to demonstrate that it was not enough.

         430 Meanwhile, early in 1991, concerns had been raised about the disposal of
         protein produced from the rendering of SBO. SEAC had been consulted and advised
         that it was not satisfactory that it should be spread on fields as fertiliser. This led to
         the introduction of a statutory requirement that disposal of protein derived from
         SBO would have to be effected under licence, to be granted by MAFF.59 The
         licensing scheme required data to be kept of weights of SBO received by renderers
         and of the protein derived from it, which enabled a rudimentary check to be made
         that SBO had not gone astray at the renderers.
         58
              The NPU BSE-to-sheep experiment was to show that ½ gram was enough
84       59
              The Bovine Spongiform Encephalopathy Order 1991, article 9
                                                                      THE ANIMAL HEALTH STORY


431 The VFS continued to make regular visits to renderers to monitor the practice
of keeping SBO separate from other material. These gave no indication that the
position was other than satisfactory.

Slaughterhouses

432 Mr Baker’s instructions to Divisional Veterinary Officers about monitoring in
November 1990 had focused on information to be provided about the handling of
SBO at renderers. They included, however, a request that visits should be made to
slaughterhouses in order to discover ‘how slaughterhouses are handling specified
offal’. The response to this request varied so much in format and detail that a further
round of reports was called for. For these a pro forma was used which called for
information about brain removal, staining and movement permits. No mention was
made of ensuring separation between SBO and other material. Not until August
1992 were field staff expressly instructed that the ‘essential feature in effective
control’ was ensuring that SBO was kept separate from other material in the
slaughterhouse and during transportation to rendering plants.

433 Both before and after these instructions, the returns received in respect of visits
to slaughterhouses gave a satisfactory picture of practices observed. There were
occasional reports of failures to observe the requirements of the human SBO
Regulations in relation to staining or movement permits, but not to an extent that
was significant.

434 This picture contrasted with a series of unofficial reports to MAFF of evasion
of the animal SBO ban. In November 1990 Mr Lawrence was invited by Mr Peter
Carrigan, who had a substantial business operating the gut rooms of slaughterhouses
under contract, to visit a gut room to see the operations involved and to consider
whether existing controls were sufficient. Mr Carrigan was in no doubt that they
were not, and that there was widespread evasion of the animal SBO ban. This visit
led Mr Lawrence to question the adequacy of the monitoring that MAFF was
providing and to suggest that weight checks should be carried out at slaughterhouses
and renderers to verify that the weight of SBO reflected the number of animals
slaughtered. This suggestion was considered to be impractical by the members of
MAFF’s Meat Hygiene Veterinary Section.

435 Mr Lawrence also suggested that a distinctive marker might be added to SBO,
thus facilitating its identification in and after it had left the slaughterhouse. We had
evidence that enquiries were made as to whether a cheap marker or stain could be
developed for this purpose. They did not lead to a successful outcome, but we were
not able to establish why this was.

436 Reports continued to come in from ‘trade sources’, some considered reliable,
that the Regulations were being disregarded and that SBO was being consigned by
slaughterhouses to renderers unstained. One source of such information was
Prosper De Mulder, the major UK renderer. This was typical of the cooperation
provided by this company to MAFF throughout the BSE story. The company
operated to high standards and showed a consistent concern that the Regulations
should be effectively implemented.

                                                                                           85
FINDINGS AND CONCLUSIONS


         437 This concern was shared by Mr Meldrum. His reaction to reports of disregard
         of the Regulations was to seek to improve the rigour of the monitoring by the VFS.
         In August 1991 a Circular was issued to the field staff, informing them of reports
         of non-compliance with the Regulations and instructing them to carry out the
         occasional unannounced visit to slaughterhouses. Notwithstanding this, the reports
         from the VFS continued to portray a satisfactory picture so far as slaughterhouse
         practices were concerned.

         Knacker’s yards and hunt kennels

         438 Officers of the VFS were instructed to make monthly visits to knacker’s yards
         and hunt kennels; the frequency reflected the fact that these premises were subject
         to significantly less local authority supervision than slaughterhouses. The
         instructions given were that on these visits staff should review ‘the procedures for
         the disposal of waste material generally and the specified offals in particular’. We
         are not, however, aware of any returns which dealt with the manner in which SBO
         was handled at knacker’s yards and hunt kennels. The only relevant Regulations
         were the MSSR 1982. These required all knacker meat to be treated as unfit for
         human consumption. They provided for staining and for movement permits in
         relation to this, but made no specific provisions in relation to SBO. We believe that
         this is why the returns from the VFS made reference, on occasion, to non-
         compliance with the MSSR but no reference to the handling of SBO.

         ‘Cradle to grave’ reviews

         439 A significant improvement in the monitoring of the handling of SBO was
         introduced on the initiative of Mr Simmons in April 1993. He recognised that
         individual reports on slaughterhouses and on renderers did not give headquarters a
         complete picture of SBO disposal. He issued a new pro forma, Form MH6. This
         extended the scope of the return to cover all aspects of SBO handling from the
         slaughterhouse, to the collection centre, to the renderer and to the final disposal of
         the protein derived from the rendering of the SBO. Confirmation was sought that
         SBO was separated from other material at all stages of its journey.

         440 In 1993 three sets of the new ‘cradle to grave’ returns were summarised by
         Mr Simmons. They indicated that practices were almost universally satisfactory.
         Occasional infringements ‘of a minor nature’, such as failing to stain all SBO or
         failing to identify SBO lines, were drawn to the attention of the local authorities,
         which took remedial measures.

         The truth emerges

         441 Despite the rosy picture painted by the returns from the VFS, unofficial reports
         of disregard by slaughterhouses of the Regulations were becoming more frequent.
         These reports led Mr Crawford to issue instructions on 1 February 1994 that all
         renderers processing SBO should be visited during the month of February
         unannounced. Full and detailed reports were to be provided of what was found.
         In summarising these reports on 25 March, Mr Simmons observed that both at
         collection centres and at renderers the constituents of stored material awaiting
86       processing had to be taken on trust. His conclusions were that a small but significant
                                                                    THE ANIMAL HEALTH STORY


amount of the total SBO processed, as a result of being inadequately identified and
separated from other material at the slaughterhouse, in transit or at the rendering
plant, was finding its way into processed protein that was being incorporated in
animal feed. It was to become apparent that the only error in Mr Simmons’s
conclusions was that the amount in question was not small.

442 Mr Simmons included in his report a number of recommendations for
tightening controls on the handling of SBO. Mr Meldrum called two meetings of
officials in the course of April to consider these. Some of the deficiencies in the
animal SBO Regulations which we have described above were recognised – it
seems for the first time – namely:

   •   The animal SBO ban did not require the separation of SBO from other
       material at all stages.
   •   The 1989 human SBO Regulations did not apply to knacker’s yards.

443 Various measures were considered, including the requirement that SBO
should be stained with a special dye.

444 On 3 May Mr Eddy, who had taken over as head of the Animal Health (Disease
Control) Division in June 1993, chaired a meeting to consider the way ahead. He
later wrote that at this meeting:

       We spent a great deal of time clarifying in our own minds how the current
       arrangements work.

445 This was an exercise that should have been done in 1990 when the animal SBO
ban was initially introduced. It was only from 1994 onwards that suitable legislative
changes were prepared, including the requirement for a special dye for SBO, a
requirement for SBO to be kept separate from non-SBO material, an approved
system of movement permits, and a requirement that renderers handling SBO
should be licensed.

The penny drops

446 It was at about this time that MAFF officials began to appreciate the true
significance of breaches of the animal SBO ban. The numbers of BABs were
soaring. In September 1993 the total had exceeded 4,000; by September 1994 it was
to reach nearly 13,000. It was apparent that some had been born after the animal
SBO ban had come into force. MAFF officials, including Mr Wilesmith,
Mr Bradley and Mr Meldrum, were reaching the conclusion that the likely cause
was double contamination:

       i.    contamination of MBM used for pig and poultry feed with SBO; and
       ii.   contamination of cattle feed with pig and poultry feed.

447 This led Mr Meldrum to initiate a review of arrangements for the disposal
of SBO. Subsequent developments were attributable in large measure to the
commendable lead of Mr Meldrum.
                                                                                        87
FINDINGS AND CONCLUSIONS


         448 In July 1994, because of pressure of work in Mr Eddy’s division, Dr Richard
         Cawthorne, the head of the Animal Health (Zoonoses) Division, was asked to
         ‘assume overall responsibility for progressing changes to the SBO controls and
         produce an action plan’. He was assisted by Mr Fleetwood, a Senior Veterinary
         Officer (SVO) in his division. Mr Fleetwood carried out an informal telephone
         survey of the quantities of SBO received by the major UK rendering plants. He
         compared this with the amount that ought to have been generated from the cattle
         being slaughtered. The weekly total was 400 tonnes short of the 1,200 tonnes which
         was his average estimate for the time of year. He concluded that the ‘SBO controls
         were not working’.

         449 Two further factors added to the gravity of the situation:

              •     In March 1994 preliminary results of a European study on the effect of the
                    rendering process on inactivating BSE had demonstrated that the three
                    systems that collectively provided most of the UK rendering capacity did not
                    provide effective inactivation.
              •     In the summer of 1994 initial results of the CVL’s attack rate experiment
                    indicated that as little as 1 gram of infective material was capable of
                    transmitting BSE orally to a cow.60
         The potential consequences of cross-contamination at the renderers and in the
         feedmill were all too plain.

         450 On 10 August the new Minister of Agriculture, Mr William Waldegrave,
         received a submission proposing radical changes to the animal SBO ban (along with
         changes to the human SBO ban). In agreeing that they should go to consultation, the
         Minister expressed concern that ‘the controls should be made as simple as possible’.
         A lengthy consultation period then ensued, which resulted in the introduction of
         new provisions after the Meat Hygiene Service had replaced the local authorities in
         the slaughterhouses.

         The Meat Hygiene Service takes over and a new SBO stain is
         introduced

         451 On 1 April 1995 the Meat Hygiene Service (MHS) was launched as an
         Executive Agency of MAFF. It took over from local authorities responsibility for
         meat inspection and enforcement of the legislation relating to meat hygiene and
         SBO controls in slaughterhouses and head-boning plants. At the same time,
         Regulations were introduced which required SBO to be stained with a new
         distinctive food colour, Patent Blue V, instead of the previous black stain, which
         was used for other unfit meat.61 This new stain had been identified as suitable the
         previous autumn, following instructions given by Mr Meldrum.

         More shortcomings revealed

         452 Most of those who had worked in slaughterhouses for local authorities as Meat
         Inspectors, EHOs or OVSs transferred their employment to the MHS. With the
         60
              The fact that the NPU had already transmitted BSE to a sheep with an oral dose of only ½ gram of infective material appears
              to have been overlooked
88       61
              The Bovine Offal (Prohibition) (Amendment) Regulations 1995
                                                                         THE ANIMAL HEALTH STORY


MHS in place it was possible for both the MHS and the VFS to carry out rigorous
monitoring of the standards of enforcement of the Regulations applied by the staff
that the MHS had inherited. It quickly became apparent that there were widespread
failures to dye SBO with the new dye, or indeed with the old one. Mr Peter Hewson,
a senior official in the Meat Hygiene Veterinary Section, commented in a minute:

           It is clear to us that the local authorities were not implementing the staining
           requirements of the SBO regulations with the diligence we would have
           expected.

453 In the first three weeks of June, under the leadership of Mr Fleetwood, the
VFS carried out a period of national surveillance, in the course of which every
slaughterhouse known to handle bovine material received an unannounced visit on
which a thorough inspection was carried out. Mr Fleetwood summarised the result:

           The overall impression of this snapshot view of the industry is that there is
           widespread and flagrant infringement of the regulations requiring staining of
           SBO. Insofar as this may reflect the general attitude of the industry to
           controls on SBO, it is of concern. Although the problems with separation are
           less extensive, there are grounds for suspecting that the highest risk tissues
           (brain and spinal cord) have been mixed with other by-products and
           processed for animal consumption . . . a careless attitude to separation and
           disposal seems to be prevalent and it is probably leading to accidents during
           disposal.62

454 It is right that we should emphasise here a point made by a number of MAFF
witnesses. Responsibility for implementing the human SBO Regulations lay with
the operators of the slaughterhouses. Responsibility for enforcing the Regulations
rested fairly and squarely on the local authorities, not on MAFF. The legislation did
not even provide for MAFF to exercise a monitoring role.

455 We have drawn attention to the fact that the human SBO Regulations did not
require SBO to be kept separate from other unfit material. They did, however,
require SBO to be stained, whether or not mixed with other unfit material. This
requirement was frequently disregarded. Slaughterhouse operators were not
fulfilling their statutory obligations and local authorities were not enforcing them.

456 We have suggested that one reason for this was that the Regulations were
designed for the protection of human health, and there were no concerns that failure
to stain might result in SBO getting into the human food chain. This may explain,
but cannot excuse, breaches of statutory duty. There were many other reasons for
these:

     •     Budgeting constraints meant that some local authorities did not employ
           sufficient staff to carry out slaughterhouse inspection duties satisfactorily.
           Nor was it easy to recruit staff. This was particularly difficult in the case of
           the OVSs – who should have been the most important members of the team.
           Veterinarians tended not to relish slaughterhouse duties and we had evidence
           that, when it was possible to recruit these, often from overseas, their quality
           was sometimes poor.

62
     YB95/7.04/3.3, para. 5                                                                   89
FINDINGS AND CONCLUSIONS


              •     There was often resentment on the part of slaughterhouse operators, Meat
                    Inspectors or both at the imposition at the top of the inspection hierarchy of
                    the OVS, whose need and function was considered to be open to question.
              •     There was a lack of effective line management. Meat Inspectors were often
                    left to their own devices, without supervision, and tended to become ‘almost
                    part of the plant staff’, getting involved in trimming and perhaps even
                    dressing, rather than keeping themselves removed and recognising their
                    roles as enforcement officers.
              •     Local authorities were often reluctant to be over-exacting in respect of
                    slaughterhouses that provided local employment and a local service to
                    farmers, but were operating on the margin of solvency.
              •     Under the Government’s deregulation initiative, there was a culture of ‘light
                    touch’ regulation. At the same time there was a media campaign which
                    pilloried local authority enforcement officials as ‘bureaucrats from hell’ or
                    ‘little Hitlers’.

         457 More than half the plants visited in June 1995 were not meeting the statutory
         requirements on staining, and 60 out of 435 plants were not separating SBO
         correctly from other material. Sixteen were not separating it at all. This was the
         lamentable state of affairs that confronted Mr Douglas Hogg when he replaced
         Mr Waldegrave as Minister of Agriculture on 5 July 1995.

         The new Order

         458 One of Mr Hogg’s first actions was to approve the terms of the proposed new
         Order,63 after having carefully discussed their implications with the Parliamentary
         Secretary, Mrs Angela Browning, and with his officials.

         459 The Order was admirably comprehensive and yet satisfied Mr Waldegrave’s
         request that it should be simple. In a single piece of legislation, enacted under the
         Animal Health Act 1981, it contained provisions aimed at protecting both human
         and animal health. Those aimed primarily at protecting animal health included the
         following:

              •     a ban on feeding SBO to animals;
              •     a ban on using SBO in the preparation of animal feed;
              •     a ban on selling SBO for feeding to animals or for use in the preparation of
                    animal feed;
              •     a requirement that brain and eyes should not be removed from the head and
                    that the head should be disposed of as SBO;
              •     a requirement that SBO should not come into contact with any other animal
                    material in the slaughterhouse;
              •     a requirement that SBO be marked with Patent Blue V;
              •     a requirement that SBO be removed to an approved collection centre,
                    rendering plant or incinerator;

90       63
              The Specified Bovine Offal Order 1995
                                                                      THE ANIMAL HEALTH STORY


   •   a requirement that SBO be kept separate from all other animal material in
       transit, at the collection centre and at the renderer;
   •   a requirement for weight-recording and record-keeping by all those
       generating or disposing of SBO;
   •   a requirement for dedicated SBO facilities at rendering plants.
The last requirement had proved controversial during consultation. It was
Mr Meldrum who insisted on its inclusion. Renderers were granted a period of six
months to introduce new dedicated lines. The new Order came into force on 15
August 1995.

460 Meanwhile the VFS had carried out two further rounds of intensive
unannounced visits, and the MHS management introduced training and awareness-
raising for the staff that they had inherited to rectify the shortcomings that had been
disclosed.

461 On 29 September Mr Fleetwood was able to report that the amount of SBO
being processed had increased by over 100 per cent. A minor part of this increase
was attributable to the fact that whole heads were now treated as SBO. The balance
is indicative of the extent of the previous evasion of the Regulations. It suggests that
the 33 1/3 per cent shortfall identified by Mr Fleetwood’s telephone survey was
probably not far short of the mark.

462 Although there had been a significant improvement by September, the VFS
was still finding widespread failure to comply with the Regulations. Up to this point
MAFF officials and Ministers had been comforted by the belief that the
shortcomings discovered did not endanger human health. However, towards the end
of October 1995 Mr Meldrum had the unenviable task of informing the Chief
Medical Officer, Dr Kenneth Calman, of four instances where spinal cord had been
found in carcasses that had been health stamped by Meat Inspectors. Mr Packer
suggested that Mr Hogg should call in the slaughterhouse owners and ‘read the riot
act’.

463 Mr Hogg did just that. On 8 November he issued ‘formal instructions’ to
Mr Johnston McNeill, Chief Executive of the MHS, calling upon him to ‘make
every effort to secure 100% compliance’ with the Regulations. This was an extreme
step for a Minister to take in relation to an Executive Agency.

464 On the following day, Mr Hogg called in slaughterhouse operators and read
the riot act. He told them that he would only be satisfied with 100 per cent
compliance with the rules. This ambitious goal was not achieved, but the concerted
efforts of the slaughterhouse operators, the MHS and the VFS produced impressive
results. Whereas in October the VFS visits had disclosed that 31 per cent of
slaughterhouses had failed to comply with the Regulations in one respect or another,
by November this proportion had dropped to 13 per cent. By the beginning of
January, Mr Fleetwood was able to report that:

       Very few problems are now being recorded other than a few lingering
       defects in staining and record keeping.

Of 344 visits made, only 5 per cent were recorded as unsatisfactory.
                                                                                           91
FINDINGS AND CONCLUSIONS


         465 Knacker’s yards and hunt kennels were included in the enforcement campaign.
         Mrs Browning met with their representatives to emphasise the need for
         improvement. Once again a remarkable improvement was produced. In one month
         alone, the proportion of visits to these premises which proved unsatisfactory
         dropped from 65 to 29 per cent.

         466 By the end of 1995 MAFF had published a list of head-boning plants,
         incinerators and collection centres which had been inspected and which were
         approved under the 1995 Order to receive SBO. Renderers proceeded to upgrade
         their plant in order to provide dedicated lines for processing SBO as required by the
         Order. In some cases, short extensions of the six-month deadline had to be granted.
         On 13 March 1996 MAFF published a list of renderers approved to handle SBO
         together with a further list of head-boning plants, incinerators and collection
         centres.

         467 Thus, by the end of the period with which we are concerned, there was at last
         in place a sound set of Regulations, imposing an effective animal SBO ban which
         was being properly implemented and monitored. At this point the abrupt change in
         perception of the risk that BSE posed to humans led to the imposition of a blanket
         ban on feeding animal protein to animals. The animal SBO ban became history.



         Did the provisions of the animal SBO ban matter?

         468 To what extent were the shortcomings that we have described attributable to
         the defects in the provisions of the animal SBO ban that we identified at the outset
         of this section?

         469 Mrs Attridge, who was head of the Animal Health and Veterinary Group
         which had responsibility for the animal SBO ban, and Mr Meldrum each submitted
         to us that improvements in the Regulations would have had no significant effect
         on enforcement in slaughterhouses so long as the District Councils remained
         responsible for this. They suggested that it was the introduction of the MHS that
         enabled the tightening of standards in slaughterhouses in and after 1995. This was
         achieved by consolidating all the Regulations into a single instrument under the
         Animal Health Act 1981. The MHS enforced the consolidated Regulations in the
         slaughterhouses and the County Councils enforced them elsewhere. Before the
         MHS took over, there was no practical way of ensuring that separation of SBO from
         other material was enforced in the slaughterhouse. Mrs Attridge added that if there
         had been problems in getting slaughterhouses to apply a single black stain – which
         there certainly had – a requirement that SBO should be marked with a separate blue
         stain would have been likely to have compounded those problems.

         470 There is force in these points. The regime under which some 300 different
         councils throughout Great Britain shared responsibility for enforcing Regulations in
         slaughterhouses had proved to have a severe structural weakness. No changes in
         Regulations would have overcome that weakness. Furthermore, the District
         Councils were not concerned with animal health Regulations. The County Councils,
         which had to enforce these, had no presence in slaughterhouses. Plainly the human
         SBO ban and the animal SBO ban could not sensibly be consolidated into a single
92       Order so long as this situation prevailed. Nonetheless, we believe that if the animal
                                                                    THE ANIMAL HEALTH STORY


SBO ban had been imposed by a detailed code such as that introduced in 1995, the
benefits would have been considerable. A statutory obligation to stain SBO with a
distinctive stain and keep it separate at all times from all other material would have
made it quite clear to slaughterhouse operators what their duty was. Meat
Inspectors, EHOs and OVSs employed by the District Councils would in practice
have had to have regard to that obligation in the course of enforcing the human SBO
ban – indeed the terms of the human SBO Regulations could have been amended to
bring them into line. The VFS would have been in no doubt as to the obligations that
it was monitoring – and the distinctive stain would have helped it in its task.

471 So far as knacker’s yards, hunt kennels, collection centres, transit to renderers,
and rendering plants were concerned, there is no doubt that it would have been
possible to impose clear and simple statutory obligations to keep SBO separate from
other material. The County Councils would have been responsible for enforcing
these. We are in no doubt that this would have resulted in significantly more
effective enforcement and monitoring of the animal SBO ban.



Why did it take so long?

472 In July 1995 Mr Packer commented in a minute to Ministers:

       The unsatisfactory treatment of specified bovine offal in slaughterhouses
       reflects an unfortunate state of affairs which has presumably existed for
       many years. We must expect questions on why we allowed the situation to
       persist for so long.

473 We asked many witnesses why it was that the VFS did not identify the
shortcomings in slaughterhouses earlier than 1994. Most had no answer to make,
other than that the shortcomings that were revealed in 1995 were a recent
development. This suggestion we reject. We are satisfied that they had persisted
throughout.

474 Mr Fleetwood suggested that the problem was that, whether or not visits were
made by formal appointment, slaughterhouses would have had advance warning of
them. ‘Unannounced’ visits might have fallen into a pattern so that they were
anticipated. Slaughterhouses would have taken steps to ensure that the right bins
were in place and liberal quantities of stain being applied when MAFF veterinarians
arrived.

475 These suggestions were speculative, but we think that there may be something
in them. The VFS had no right of access to slaughterhouses. It would not have been
easy simply to turn up to carry out an inspection without liaising with the local
authority responsible for enforcement. The truly unannounced and unexpected visit
may well have been a rarity.

476 Mr Fleetwood also suggested that animal health officers making the visits
may have been fairly recent recruits to the VFS and ‘easily browbeaten’ by
slaughterhouse managers. There may also be some truth in this suggestion. We
believe, however, that before 1995 inspections by members of the VFS were much
                                                                                         93
FINDINGS AND CONCLUSIONS


         less rigorous than after the MHS had taken over. There were a number of reasons
         for this.

            •   Before 1994 the practical importance of the animal SBO ban was not
                appreciated. It appeared to be a precautionary measure to protect pigs and
                poultry that was probably unnecessary.
            •   The growing number of BABs and the result of the attack rate experiment
                led, in 1994, to the realisation that the animal SBO ban was a crucial element
                in the eradication of BSE.
            •   Before 1995 VFS visits were made ‘on sufferance’. After 1995 they were
                made with the support of the MHS.
            •   Before 1995 the VFS visits were not targeted, for there were no Regulations
                requiring SBO to be kept separate from other unfit material. After 1995 there
                were specific statutory requirements to be monitored.

         477 We consider that these are all factors which tend to explain why the
         shortcomings discovered in 1995 were not identified earlier by the VFS. MAFF
         officials were, however, receiving regular reports from unofficial sources that,
         contrary to the reports that were being made by the VFS, the animal SBO ban was
         being evaded. Are they to be criticised for not reacting more rigorously to these
         reports? Their reaction was steadily to step up the stringency of monitoring by the
         VFS until, finally, its reports confirmed the unofficial ones. Once again we have
         concluded that the failure to respond more positively was attributable to the failure
         to focus at the outset on the possibility that a very small quantity of infectious
         material might suffice to transmit BSE to cattle. As the years passed without cases
         of transmission of BSE to pigs and poultry, it must increasingly have seemed that
         the concerns which had given rise to the animal SBO ban were unfounded.

         478 When in 1994 it was appreciated that shortcomings in the enforcement of the
         animal SBO ban were probably leading to the infection of cattle, Mr Bradley of the
         CVL concluded: ‘We have to quickly and effectively re-assess and, if necessary,
         improve the policing of the controls both via MAFF and the Local authorities.’ We
         believe that Mr Meldrum and his colleagues reached the same conclusion. Are they
         to be criticised for not reaching it sooner? Once again we have concluded that the
         failure to respond more positively was attributable to the original failure to explore
         the minimum amount that might infect and thus to focus at the outset on the danger
         of cross-contamination at the time of introduction of the ruminant feed ban. Given
         that failure, we do not consider that the manner in which MAFF officials performed
         their role of policing the animal SBO ban fell outside the range of acceptable
         responses to the facts as they appeared at the time.



         Two fundamental issues

         479 The story that we have set out raises two fundamental issues:

            •   should the feeding of all animal protein to animals have been banned from
                the outset? If not,

94
                                                                    THE ANIMAL HEALTH STORY


   •   should the requirement that SBO be processed in dedicated rendering
       facilities have been imposed from the outset?

480 The practice of feeding animal protein to animals was considered, in the
context of BSE, by the Southwood Working Party, by SEAC and by the Lamming
Committee. None considered that the practice should be stopped, or even that the
practice of feeding ruminant protein to pigs and poultry should be stopped. The total
ban on feeding animal protein to animals that was imposed pursuant to SEAC’s
recommendation in March 1996 was a reaction, and a reasonable reaction, to the
horror of discovering that BSE was probably transmissible to humans. Its
consequence was to turn renderers into a waste disposal industry rather than
producers of a valuable animal by-product. We do not consider that it is cause for
criticism that MAFF officials, MAFF Ministers and MAFF’s expert advisers did not
consider that this step was justified prior to 1996.

481 Had the possibility that a very small amount of infective material in feed would
suffice to transmit BSE been appreciated, we feel that this should have led to the
conclusion that it was unsatisfactory to use the same plant to render sequentially
SBO and offal for incorporation in animal feed. We have already criticised the
failure to give consideration to the possibility that a small quantity would infect at
the time of the introduction of the ruminant feed ban.

482 Given that failure, we would not criticise MAFF officials for not insisting that
SBO should be rendered in dedicated facilities. The considerable cost that this
would have imposed on renderers could reasonably have been considered
disproportionate if its only purpose was to enhance the protection of pigs and
poultry against what was no more than a possible risk. Once perceptions had
changed in 1994, Mr Meldrum is to be commended for having insisted that
renderers should be required to provide dedicated facilities if they were to be
permitted to process SBO.



Conclusions

483 We have reached the end of a black chapter in the BSE story. There are lessons
to be learned from it, which we consider later. At this point we have a few
concluding remarks.

484 Mr Meldrum was correct to stress the structural problems prior to 1995 of
enforcing Regulations in slaughterhouses. The MHS was not introduced as a
response to the problems of BSE. Its introduction was, nonetheless, of the greatest
significance in addressing the dangers that BSE posed to the human and animal food
chains.

485 The SVS, of which the VFS was one arm, had no statutory role in relation to
the enforcement of the SBO Regulations. The monitoring role that it had undertaken
was essential. Statutory recognition of that role, and statutory power of entry in
support, would have been desirable.

486 In the event, largely as a result of the direction of Mr Meldrum, the SVS found
itself increasingly filling the gaps in the statutory machinery for enforcing the        95
FINDINGS AND CONCLUSIONS


         animal SBO ban. One example was the monitoring that the VFS undertook of
         collection centres. Another was the negotiation with UKRA of the Code of Practice
         that was introduced in order to reduce cross-contamination at the renderers.

         487 Finally, we should recognise the credit due to the continued efforts of the
         MHS, the SVS and slaughterhouse operators themselves, spurred on by the
         vigorous intervention of Mr Hogg, in turning round in 1995 what, up to then, had
         been a most unsatisfactory state of affairs. They were assisted in doing so by the
         belated introduction of an excellent regulatory scheme.



         Cattle-tracking
         488 There are two other topics which properly fall within the context of animal
         health. The first of these is cattle-tracking. Had MAFF had in place a computerised
         system under which the movements of cattle could be traced back to their place of
         birth, and their dams identified, this would have been of great benefit in satisfying
         European requirements that beef exported should have a BSE-free provenance. This
         we can see with hindsight. When BSE emerged, however, the immediate question
         was whether such a system needed to be put in place either to meet the demands of
         controlling BSE, or to meet the demands of disease control that might arise from the
         emergence of other new diseases.

         489 That question was considered in 1990 by the Agriculture Committee of the
         House of Commons and answered in the affirmative. It was subsequently explored
         by MAFF officials in the context of a wider consideration of future information
         technology requirements. Officials concluded that neither the demands of BSE, nor
         those of disease control in relation to any foreseeable new disease, could justify the
         expense of introducing a computerised animal-tracking system. In vol. 5: Animal
         Health, 1989–96 we have reviewed that conclusion and decided that it is not one we
         would criticise. We make no comment, for it is not within our terms of reference,
         on MAFF officials’ response to the wider demands and possibilities of information
         technology.



         Breeding

         490 The other topic which falls within the context of animal health is that of
         breeding. In 1990, when it was unclear whether, or to what extent, BSE was a
         disease which would be maternally transmitted, a practical problem arose of
         concern to farmers: should they use the offspring of BSE cattle for breeding?

         491 The British Veterinary Association and the MAFF veterinarians, headed by
         Mr Meldrum, were of one mind. Farmers should be advised that it was not desirable
         to breed from the progeny of BSE victims. Dr Pickles, who led in relation to BSE
         on behalf of DH, learned of this proposed advice. She considered that it was open
         to a number of objections, more political than veterinary, which MAFF officials had
         overlooked. SEAC had just been set up, and Dr Pickles succeeded in persuading
         Ministers that the new committee should be requested to consider the proposed
96       advice.
                                                                    THE ANIMAL HEALTH STORY


492 SEAC did so at its first meeting, and expressed agreement, then and there, with
Dr Pickles’s reservations. We for our part had reservations about the use that was
made of SEAC on this occasion and its outcome, though they did not lead us to
criticise anyone involved. A full discussion of this matter is to be found in vol. 11:
Scientists after Southwood.

493 The result was that MAFF did not advise farmers against breeding from the
offspring of cattle which had been affected with BSE. An Advisory Note to farmers,
which was issued in 1990, simply recommended that, if in doubt, farmers should
consult their vet. Such a recommendation was not very helpful to farmers who
received it. Given SEAC’s advice that farmers should not be advised not to use the
offspring of BSE cattle for breeding, we do not criticise the approach adopted in
MAFF’s Advisory Note.




                                                                                         97
     6. Protecting human health

     Introduction

     494 We now turn to that part of the BSE story that has direct relevance to human
     health. There are many aspects to this part of the story. The main part of this chapter
     will follow a chronological sequence. However, we propose to introduce at the
     outset the CJD Surveillance Unit, which was to play a key role in the latter stages
     of the human health story; and to discuss at the outset as a discrete topic the
     slaughter and destruction of animals showing signs of BSE and the compensation
     paid to the owners of those animals.

     495 The most obvious pathway by which BSE might be transmitted from cattle to
     humans was by the food chain. It was that pathway which caused concern to the
     public. And it was the public’s concern about that pathway which was of concern to
     the Government. The Government was anxious to do all that it believed to be
     necessary to protect human health. But having taken that action, it was anxious to
     reassure members of the public that their health was not at risk. MAFF had a dual
     role. It had to make sure that meat which left a slaughterhouse was safe to eat. That
     was its prime concern. But it also had to have regard to the interests of the farming
     industry. There was a continuous concern on the part of MAFF officials and
     Ministers that the agricultural industry would be damaged by reactions to BSE on
     the part of the public that were irrational. This concern did not lead them to conceal
     information from the public. It did, however, lead them to attempt to ensure that
     information was presented in a manner that would not cause alarm. This sometimes
     involved delaying disclosure of information. It involved repeated statements that
     there was no evidence that BSE was transmissible to humans. It involved attempts
     to present to the public in the most compelling way the message that it was safe to
     eat beef.

     496 This part of our narrative will follow the BSE story of which the public were
     aware: the events which provoked apprehension on their part and the statements that
     were made to them about the risk posed by BSE. It will examine the policy decisions
     that the Government had to take in relation to potential dangers posed by BSE to the
     human food chain. It will look in particular at public pronouncements and
     government action in the final months leading up to 20 March 1996.

     497 We shall deal later, as separate topics, with aspects of the BSE story of which
     the general public were unaware:

        •   Action taken in relation to human and veterinary medicines.
        •   Action taken in relation to cosmetics.
        •   International trade.

     498 Finally we shall consider the experience of those young victims who were
     struck down by vCJD and of their families, in order to see what lessons can be
     learned about dealing with this terrible disease.
98
                                                                   PROTECTING HUMAN HEALTH


CJD surveillance

Surveillance recommended by the Southwood Working
Party and the Tyrrell Committee

499 Although the Southwood Working Party thought that it was most unlikely that
BSE would have any implications for human health, they considered how BSE
might appear, and be recognisable, if it did transmit to humans.

500 The Southwood Working Party noted in their Report that it was a reasonable
assumption that, were BSE to be transmitted to humans, the clinical disorder would
closely resemble CJD. They suggested that consideration be given to whether
specialist branches of the medical profession, such as neurologists, should be made
aware of the emergence of BSE so that they could report any atypical cases or
changing patterns in the incidence of CJD. They also suggested that epidemiologists
should be advised to watch for any such changing patterns.

501 CJD surveillance was also considered by the Tyrrell Committee. The Tyrrell
Report gave the highest priority to the monitoring of all UK cases of CJD over the
following two decades.

The CJD Surveillance Unit established

502 In December 1989 Dr Robert Will, then a consultant neurologist, applied to
the Department of Health for a research grant for a project on CJD surveillance.
Between 1979 and 1982, Dr Will had worked with Professor Bryan Matthews on
various studies relating to the surveillance and analysis of CJD cases in England and
Wales. Dr Will’s proposal was accepted and the CJD surveillance project began on
1 May 1990 at the Western General Hospital in Edinburgh. It covered the whole of
the UK and developed links with the surveillance networks of other countries.

503 The main objectives of the CJD Surveillance Unit (CJDSU) study were to
identify any change in the epidemiological characteristics of CJD and to assess
the extent to which any such changes were linked to the occurrence of BSE.
The CJDSU was expected to document and publish any changes in the clinical or
other characteristics of CJD, or in the epidemiology of the disease, and conduct
investigations into the cause of these changes. The CJDSU summarised its progress
and findings in a series of annual reports. These annual reports were supplemented
by Dr Will informing SEAC and DH of developments.

How the surveillance system worked

504 The CJDSU needed to establish a system for the surveillance of CJD that
would be able to detect any changes in epidemiology or clinical characteristics,
as a result of the emergence of BSE. The main factors investigated included the
number of cases of CJD, geographical distribution of cases and occupational
incidence.


                                                                                        99
FINDINGS AND CONCLUSIONS


         505 Primarily, this surveillance was achieved by seeking and obtaining direct
         referral of any suspect cases of CJD from neurologists. These professionals were
         also asked to report all cases of subacute dementing illnesses or progressive
         cerebellar dysfunction in specific occupational groups (including farmers and
         slaughtermen). However, as a precaution, all death certificates mentioning CJD
         were also obtained and assessed.

         506 A standard questionnaire was used to obtain data relevant to diagnosis and
         ascertainment of possible risk factors. The questionnaire used by the CJDSU was
         based on the previous one developed by Dr Will for his work with Professor
         Matthews. It included sections on patients’ initial symptoms, past medical history,
         family history, social history (residential, occupation, diet), exposure to animals,
         clinical history and results of diagnostic investigation. Minor changes were made to
         it before it was used in 1991 and subsequent alterations were made throughout the
         period 1991–95, as knowledge of CJD developed.

         507 Unlike BSE, CJD was not made a notifiable disease. The possibility of making
         CJD a notifiable disease was not supported by either the Chief Medical Officer or
         Dr Will. Dr Will considered that in order to make CJD a notifiable disease, specific
         diagnostic criteria would have to be established. Some cases might then be missed
         as there might be a reluctance to notify cases that did not fulfil the criteria
         absolutely. Dr Will’s view was supported by the European Union Surveillance
         Group in 1994. Recent data from this Group have lent some further support to
         Dr Will’s view. The introduction of notification in Slovakia resulted in a decrease
         in the number of referrals.

         PHLS excluded from CJD surveillance

         508 The Public Health Laboratory Service (PHLS) did not become involved in
         CJD surveillance until after 20 March 1996. The PHLS is a public body with
         responsibility for providing a microbiological and epidemiological service to health
         authorities and local authorities for the diagnosis, control and prevention of
         infection and communicable diseases. It operates in England and Wales only,
         but has close working links with the parallel arrangements in Scotland and
         Northern Ireland.

         509 PHLS officials repeatedly raised concerns with DH about the exclusion of
         their service from CJD surveillance. Since the PHLS’s expertise was in
         communicable diseases, DH officials were concerned that PHLS involvement in the
         CJD monitoring process might indicate a belief that CJD could be spread from
         person to person. However, several other reasons were also given to the PHLS by
         DH for the decision. These included the possibility of unnecessary duplication of
         work and concern about PHLS priorities.

         510 The decision to place the responsibility for surveillance with a small research
         team of dedicated medical scientists headed by a clinical neurologist with extensive
         experience in CJD was entirely correct. In 1989 the PHLS did not have expertise in
         CJD and, most importantly, there was (and still is) no established laboratory test for
         either CJD screening or for diagnosis in suspect cases. We commend the sterling
         work of the CJDSU team, who so promptly detected the emergence of vCJD and so
         efficiently established the clinical and pathological characteristics of the disease.
100
                                                                                           PROTECTING HUMAN HEALTH


While we have formed the view that the PHLS could have contributed to various
aspects of the task assigned to the CJDSU, assistance from the PHLS would not
have enabled identification of vCJD at any earlier date. We do not criticise those
who concluded that the task of monitoring CJD should be left to the Surveillance
Unit set up for that purpose.



Slaughter and compensation

511 The slaughter and compensation scheme was designed to ensure that animals
sick with BSE were destroyed so that there was no way in which they could transmit
the disease to humans or to animals. It was a vitally important measure. We have
been concerned to investigate allegations that some farmers sent animals showing
early signs of BSE to the slaughterhouse in deliberate breach of the Regulations, and
that the reason that they did so was because the level of compensation set by MAFF
was inadequate.

512 We have seen above the circumstances in which the Government decided to
introduce compulsory slaughter of animals showing signs of BSE and the
destruction of their carcasses. It received advice that it should do this from the
Southwood Working Party on 21 June 1988. Under the Animal Health Act 1981
compensation would have to be paid for compulsory slaughter on grounds of human
or animal health. Ministers determined the level of compensation payable but had
to have the agreement of the Treasury. Exploratory discussions with the farming
industry indicated that payment of 50 per cent of market value might be considered
acceptable, provided that 100 per cent was paid in respect of any animal which, after
slaughter, was found not to have been suffering from the disease.

513 On 29 June Mr MacGregor wrote to Mr Major, the Chief Secretary to the
Treasury, seeking approval for the payment of compensation at 50 per cent of
market value. He estimated that on the basis of 60 cases a month this would cost
about £200,000 to £250,000 a year. Mr Major agreed to this on 6 July, emphasising
that he only did so because of the need to protect human health. Two Orders64 were
drafted by 22 July, and were made on 28 July and brought into force on 8 August,
abridging the three weeks that normally elapse before Orders subject to negative
resolution procedure come into force. It can be seen that no time was lost in
implementing the recommendation of the Southwood Working Party.

514 The formula for determining compensation was complicated. Broadly, but
not precisely:

     •    When the slaughtered animal proved to have BSE, the lesser of:
          i.     50 per cent of the value of that animal (in good health); or
          ii.    62½ per cent of the value of an average animal was payable.
     •    When the slaughtered animal proved not to have BSE the lesser of:
          i.     100 per cent of the value of that animal; or
          ii.    125 per cent of the value of an average animal was payable.
64
     The Bovine Spongiform Encephalopathy (Amendment) Order 1988 and the Bovine Spongiform Encephalopathy
     Compensation Order 1988                                                                                 101
FINDINGS AND CONCLUSIONS


         515 When an owner declared to MAFF that an animal was suspected of having
         BSE, but the animal died or was put down before a MAFF veterinarian confirmed
         that it appeared to have the disease, no compensation fell to be paid under the Order.
         On the recommendation of Mr Kevin Taylor and Mr Meldrum, it was agreed that
         normal compensation be paid on an ex gratia basis in those circumstances, provided
         that the animal was shown to have been suffering from BSE. When the animal did
         not have BSE, £50 was paid. This arrangement seems to us fair and we commend it.

         516 Although industry soundings made by MAFF officials had suggested that the
         level of compensation would be acceptable, it in fact provoked a sustained barrage
         of attack:

            •   8 July 1988: the National Farmers’ Union (NFU) in a press release expressed
                the view that 100 per cent compensation should be paid for all slaughtered
                cattle.
            •   2 September 1988: Mr Gordon Gresty, the County Trading Standards
                Officer of North Yorkshire County Council, expressed concern that
                compensation was only 50 per cent of market value. This might deter
                farmers from notifying suspect cases.
            •   27 September 1988: the Milk and Dairy Produce Committee of the NFU
                stressed that compensation should be 100 per cent of market value.
            •   23 January 1989: the Farmers’ Union of Wales expressed ‘complete
                dissatisfaction’ with the compensation arrangements, suggesting that the low
                level of compensation might encourage less scrupulous farmers to dispose of
                animals showing signs of BSE on the open market.
            •   17 February 1989: the first of a series of Parliamentary Questions from the
                Opposition suggesting that compensation should be raised to 100 per cent.
            •   5 May 1989: Mr Peter Walker, Secretary of State for Wales, wrote to
                Mr MacGregor passing on concerns of his Agriculture Advisory Panel that
                the level of compensation was leading to evasion of reporting. He suggested
                reviewing the position.
            •   14 June 1989: the National Consumer Council wrote to Mr MacGregor
                suggesting that, with compensation at 50 per cent, there was ‘every incentive
                for farmers to send a cow for slaughter at the earliest sign of disease . . .
                the compensation arrangements must be reviewed’.
            •   14 June 1989: the NFU wrote asking for a review of the level of
                compensation which, in their view, should be 100 per cent.

         517 To all of these submissions MAFF made the same reply. Compensation at
         50 per cent of the market value was fair. That compensation was payable for
         animals suffering from a terminal illness. The cattle were valued for the purposes of
         compensation, not as terminally ill, but as if they were unaffected with disease.
         Furthermore there was no evidence of any farmers attempting to evade the law.

         518 This response reflected the advice being given to Mr MacGregor by
         his officials.


102
                                                                   PROTECTING HUMAN HEALTH


519 In July 1989 ministerial changes brought about a change in attitude in respect
of compensation levels. On 6 September 1989 Mr David Curry, one of the new
Parliamentary Secretaries, put an aide-mémoire to Mr Gummer, the new Minister,
expressing the view that 50 per cent compensation was inadequate, and observing
that the possibility of a farmer slipping a diseased animal into the food chain could
not be absolutely denied. Officials responded recommending against increasing the
level of compensation. Mr Lowson pointed out that only 52 suspect cases had been
detected at abattoirs in the first six months of the year, of which by no means all
would have resulted from deliberate deception. Mr Curry was not persuaded, but
accepted that there was little chance of changing the position in the light of
financial constraints.

520 Pressure for an increase in compensation then intensified:

   •   4 December 1989: Mr R Cooper, a Director of Sainsburys, wrote saying that
       his company felt that ‘full compensation’ should be given for any BSE-
       infected cattle rather than 50 per cent in order to give the farming community
       every incentive to isolate diseased cattle.
   •   4 January 1990: The Times reported that ‘farmers are attempting to pass off
       diseased cattle as healthy because the Ministry of Agriculture will only
       compensate them for 50 per cent of the value of an infected beast once it
       is destroyed’.
   •   The Consumers’ Committee of the Meat and Livestock Commission (MLC)
       expressed the view that compensation should be increased.
   •   15 January 1990: a meeting of Dorset farmers expressed concern that failure
       to pay full compensation was giving the wrong message to consumers and
       could damage meat consumption.
   •   25 January 1990: the President of the NFU wrote to Mr Gummer suggesting
       that ‘raising the compensation to a more realistic level would be the most
       effective way of reassuring the public that there is no temptation for any
       farmer deliberately to send to market an animal with incipient BSE’.

521 Up to this point Ministers had continued to advance the same reasons as before
for rejecting calls for higher compensation. Mr Gummer now decided that it would
be politic to increase compensation. In a meeting with Mrs Thatcher on 30 January
1990, he suggested that compensation for the slaughter of diseased animals should
be increased to 100 per cent for two reasons. First, losses were increasing, and some
farmers were having a hard time. Second, full compensation would demonstrate that
the Government was doing everything possible to keep BSE-infected cattle out of
the food chain. The Prime Minister felt that the second was the better case and
agreed that Mr Gummer should work up a proposal for increasing the rate of
compensation, in consultation with the Treasury, which could then be put to
ministerial colleagues.

522 On 7 February 1990, after discussing the matter with his colleagues,
Mr Gummer wrote to Mr Norman Lamont, Chief Secretary to the Treasury,
proposing an increase in compensation. He stated that he did not believe that
farmers were sending BSE suspects to slaughter to any great extent, but that the
possibility that they might do so must be growing. The principal case that he made
for the increase was that this would allay public concern.                              103
FINDINGS AND CONCLUSIONS


         523 A submission to Mr Lamont from a Treasury official in respect of
         Mr Gummer’s proposal observed:

                   This is essentially a political matter, and on this basis you may wish to agree.
                   The Prime Minister is thought to be sympathetic to Mr Gummer.

         524 On 9 February 1990 Mr Lamont wrote to Mr Gummer reluctantly agreeing to
         his proposal.

         525 On 13 February 1990 Mr Gummer announced the change in policy on
         compensation to the Annual General Meeting of the NFU. The change that he
         announced was brought into force the following day.65 The new level of
         compensation for confirmed BSE cases was the lesser of 100 per cent of the
         animal’s sound market value, or 100 per cent of the average cattle value.

         Was compensation too low?

         526 We have carefully considered the level of compensation originally paid to
         farmers for the slaughter of BSE suspects. It seems to us that the compensation bore
         a reasonable relationship to the loss caused by the slaughter, and on that basis was
         fair. We would emphasise that the loss in question was not the loss consequent upon
         having a cow affected, or suspected of being affected, with BSE. The loss was that
         experienced as a result of the deprivation of such a cow. To offer 50 per cent of the
         value of a healthy cow does not seem unreasonable for an animal showing signs of
         a terminal disease.

         527 Nor would we have expected the level of compensation to have resulted in
         widespread evasion of the duty to notify. We would hope that most farmers would
         have been sufficiently principled not to seek to put into the food chain an animal
         that might endanger human life. Furthermore, to send a sick animal off to the market
         would be a chancy business, for the stress would be likely to make the symptoms
         more apparent.

         528 The evidence that we received suggests that there was not significant evasion
         of the duty to notify during the period that compensation for infected animals
         remained at 50 per cent. During December and January MAFF veterinary staff
         made nearly 300 random visits to over 180 slaughterhouses. Of 1,663 animals sent
         for slaughter that were inspected, only one suspect case was identified.

         529 Leaders within the farming industry, who gave evidence to us, expressed a
         firm belief that there was no, or negligible, failure to report suspect cases. Farmers
         gave evidence to the same effect, as did veterinarians.

         530 The 1990 Agriculture Committee in its Report commented:

                   The introduction of full compensation produced no very dramatic increase
                   in the number of BSE cases being reported but, in view of the general
                   perception that there may be under-reporting of such diseases where farmers
                   are not fully compensated, it might have been prudent, for reasons of public
                   reassurance, to have introduced it earlier.
104      65
              By the Bovine Spongiform Encephalopathy Compensation Order 1990
                                                                       PROTECTING HUMAN HEALTH


531 We agree with the Agriculture Committee that the justification for raising
compensation was the desirability of providing reassurance to the public that cattle
affected by BSE were not being slaughtered for food, rather than a need to provide
a better financial inducement to farmers to obey the law. Mr Gummer’s decision
was, essentially, a political decision. We have no criticism to make either of that
decision or of its timing.

Ante-mortem inspection

532 We have referred to random slaughterhouse inspections in December 1989 and
January 1990. These were carried out at the suggestion of Mr Meldrum, who
believed it was desirable to check that farmers were not sending off for slaughter
cattle that showed signs of BSE. Mr Gummer agreed with Mr Meldrum’s proposal.
Initially these inspections were carried out by State Veterinary Service (SVS) staff,
but from 5 February 1990 this function was transferred to Local Veterinary
Inspectors (LVIs). In 1990 LVIs inspected over 31,000 animals at slaughterhouses,
among which they identified just 29 suspects, of which only 14 were confirmed.
This certainly indicates that after compensation for BSE casualties was raised to 100
per cent, there were at most only a few deliberate attempts to send suspect animals
for human consumption. We consider that ante-mortem inspections at domestic
slaughterhouses were desirable as a check that the Regulations were being complied
with, and we commend Mr Meldrum for promoting them.

Compensation changed again

533 On 1 April 1994 a new formula for calculating compensation was
introduced.66 The change related to the method of calculating the market price
element of the formula. This was adjusted downwards to reflect the fact that a large
proportion of the cows developing BSE were older animals at the end of their
working life. The motive for this change was to save money – it was calculated that
it would reduce compensation payable by approximately £5 million in 1994/95.
We have no criticism to make of this change or of the reason for it.

Unanticipated burdens

534 When the slaughter and compensation scheme was introduced, it was
anticipated that it would apply to about 60 cattle a month. At the height of the BSE
epidemic 8,000 suspects were notified in a single month. The task of diagnosing
whether or not the suspects were infected with BSE was enormous. It was achieved
by performing histopathology on a single section of the bovine brain (the obex
section) and sharing the task of analysis between a number of Veterinary
Investigation Centres. We commend the Veterinary Investigation Service for the
efficiency with which this task was performed.

535 The other unforeseen consequence of the slaughter and compensation policy
was the horrific problem of disposing of the carcasses of thousands of slaughtered
cattle. This was a major element in the waste disposal problem to which BSE gave
rise. We shall revert to the problem of waste disposal later in this volume.

66
     By the Bovine Spongiform Encephalopathy Compensation Order 1994                     105
FINDINGS AND CONCLUSIONS


         Introduction of the ban on Specified Bovine Offal (SBO)
         in human food

         536 We have seen that the Southwood Working Party drew a sharp distinction
         between the possible risk to those who ate food derived from a cow with clinical
         signs of BSE and the risk from eating food derived from a cow incubating the
         disease, but not yet showing clinical signs (a ‘subclinical’). Clinically ill cattle had
         to be destroyed. The tissues of a subclinical were not regarded by the Working Party
         as likely to be sufficiently infective to pose a threat – except perhaps to babies.67

         537 With hindsight, we can see just how dangerous it can be to eat some of the
         tissues of a subclinical, at least for cattle, where no species barrier is involved. On
         8 August 1988 compulsory slaughter and destruction of all cattle showing signs of
         BSE was introduced. Some 40,000 cattle born since that date have contracted BSE
         and lived to develop the clinical signs. A multiple of that figure will have been
         infected but slaughtered before clinical signs developed. The vast majority of those
         cases are likely to have been infected as a result of eating feed contaminated by very
         small quantities of infective tissues of subclinicals. These had been through the
         rendering process. We have seen above how this material got into cattle feed.

         538 Since 13 November 1989, the tissues of subclinicals most likely to carry
         infectivity should not have been fed to humans. On that day a ban on using them for
         human food was introduced (‘the human SBO ban’). The introduction of that ban at
         a time when most considered it highly unlikely that BSE could be transmitted to
         humans was one of the most far-sighted measures introduced in response to BSE –
         or it would have been had it been introduced as a result of foresight. As we shall see,
         however, the process that led to its introduction was haphazard rather than the result
         of rigorous risk evaluation. Mr MacGregor, who was responsible for the measure
         that Mr Meldrum described to us as ‘inspirational’, was at pains to emphasise to us
         that scientific considerations were not the primary factor which motivated him.
         Did it matter that the process was haphazard? We think that it did. First, it meant
         that the process was protracted. Second, it contributed to a failure to emphasise the
         importance of the measure, which detracted from the rigour of its implementation.
         In this chapter we shall describe how the policy decision to introduce the human
         SBO ban came to be taken, the reasons that were given for that decision and the
         manner in which it was translated into statutory Regulations.

         Government response to the Southwood Report

         539 Good government does not blindly follow the advice of scientific experts.
         Before doing so, it must evaluate the advice to make sure that it appears sound.
         In the case of the Southwood Report this was not easy. The Working Party had not
         expressed their reasons for concluding:

              •    that all clinically sick animals should be destroyed;
              •    that the risk that BSE posed to humans was remote;
              •    that manufacturers of baby food should exclude certain bovine offal; and


106      67
              See paragraph 264 above for the baby food recommendation
                                                                     PROTECTING HUMAN HEALTH


     •     that no measures were justified to prevent others from eating offal
           from subclinicals.

540 Nor had the Working Party made it plain that they were attempting to apply
the ALARP principle.

541 Dr Hilary Pickles had the lead for DH in relation to BSE. She had been
DH secretary to the Southwood Working Party and had drafted some of the most
important parts of their Report. She wrote to Sir Donald Acheson on 6 February
1989 saying that the Report should be with him in a day or two. She commented:

           In my view DH can be very pleased with the way the report has turned out.
           Sir Richard and his team are to be congratulated.

542 Dr Pickles did, however, inform Sir Donald of one concern that was not
reflected in the Report. She was worried about the safety of bovine-based vaccines.
Sir Donald minuted Dr E L Harris, the Deputy CMO, to ask him to look into this.
Sir Donald told us that he also asked Dr Harris to conduct a complete review of the
Southwood Report. Dr Harris has died, so we could not ask him about this, but our
analysis of the evidence set out in vol. 6: Human Health, 1989–96 has satisfied us
that Sir Donald’s recollection is at fault here. He should have ensured that the
Report was reviewed by his Department, but he did not do so. No doubt he placed
confidence in the views of Dr Pickles. She was someone who inspired confidence.
But because of her involvement she was not in a position to review the Report.

543 Sir Donald forwarded a copy of the Southwood Report to the Secretary of State
for Health, Mr Kenneth Clarke, on 9 February. He commented:

           I regard it as a thorough study of the subject with sound and balanced
           conclusions.

He also expressed the view that, with one possible exception:68

           Every reasonable step has been taken to minimise any theoretical risk of
           transmission by destruction of affected cattle.

Sir Donald said nothing about the baby food recommendation.

544 When Mr Lawrence, MAFF’s secretary to the Working Party, presented the
Report to MAFF Ministers, he identified in a covering note a number of areas of
interest to MAFF. One of these was the baby food recommendation. He sent a
copy of his note, together with the Report, to ‘interested Divisions within the
Department’. Mr MacGregor raised the question of baby food at a meeting with
Sir Richard Southwood a few days later. Sir Richard commented that the point in
the Report in relation to baby food was not a specific recommendation, but a
counsel of ‘extreme prudence’.

545 The baby food recommendation was, however, causing concern to MAFF
officials, in particular to Dr Mark Woolfe of the Food Science Division, who
considered that identification of babies as a high-risk category did not appear to
have been ‘well thought out’, and to Mrs Attridge, the head of Emergencies, Food
68
     This was a reference to Dr Pickles’s concern about vaccines                       107
FINDINGS AND CONCLUSIONS


         Quality and Pest Control Group. Mrs Attridge was concerned because her
         responsibilities included the composition of food, and cow’s liver and kidney were
         a valuable source of nutrition for babies. She was concerned that the baby food
         recommendation was based not on consideration of all the relevant science, but on
         ‘poorly substantiated speculation’. Although Mrs Attridge’s concern was that the
         baby food recommendation might result, without good reason, in the removal from
         babies of valuable nutrition, she commented in minutes to Mr Cruickshank, the
         Under Secretary in charge of the Animal Health Group, that MAFF would be asked
         why action should be taken on baby food but not on other food.

         546 At a Cabinet meeting on 23 February to discuss the response to the Southwood
         Report, there was lively debate about the baby food recommendation. Mr Clarke,
         supported by Mr MacGregor, urged that the Report should be published and the
         baby food recommendation accepted. Other Ministers were concerned that
         publication of the recommendation would lead to a baby food scare. The decision
         was taken that the Report should be published after Mr MacGregor and Mr Clarke
         had prepared, with the help of the CMO, a clear and accurate statement of the
         Government’s response to the baby food recommendation.

         547 After the Cabinet meeting Sir Richard Southwood was contacted by
         Sir Donald Acheson. Sir Richard said that the baby food recommendation should
         only be treated as applying to brain, spinal cord, spleen, intestine and thymus, and
         not to heart, liver and kidney. This took the heat out of the situation. None of
         the former types of offal was included in manufactured baby food. The
         recommendation would not be likely to give rise to a boycott of baby food.

         548 On 27 February 1989 the Southwood Report was published. In a written
         announcement, Mr MacGregor explained that none of the types of offal, which were
         the subject of the baby food recommendation, were used in the manufacture of baby
         food, but that as a precautionary measure he intended to make it illegal for anyone
         to sell baby food containing such products in the future.

         549 No one in either DH or MAFF gave thought to the question that Mrs Attridge
         had warned would be raised. If these types of offal could not safely be fed to babies,
         why was it safe to feed them to children and adults? This important question was
         one that any thorough departmental review of the Southwood Report should have
         addressed. Another, linked, question that needed to be addressed was why the
         Working Party were so concerned about animals showing clinical signs of BSE, but
         not concerned, at least so far as safety of food was concerned, with the subclinicals.

         550 We have already rejected Sir Donald Acheson’s evidence that a full review of
         the Report was carried out by Dr Harris. Mr Clarke told us that in his Department
         there had been a very great deal of copious review, correspondence and discussion
         about the Report, which would have included the questions raised above, although
         he could not now remember the details of these. He also referred to an ‘amazing
         quantity of exchanges’ going on between his Department and Mr MacGregor’s.
         We did not accept this evidence. As Secretary of State for Health, Mr Clarke needed
         to be in a position to answer the question ‘If offal is not safe for babies, why is it
         safe for adults?’ He should have ensured that his Department reviewed the Report
         and provided an answer – if there was one. He did not.

108
                                                                    PROTECTING HUMAN HEALTH


551 At Prime Minister’s Questions on 28 February, Mr John Evans, from the
Opposition benches, asked Mrs Thatcher:

       If, as appears likely to the Secretary of State for Health, BSE is a threat to
       humanity, why not ban the use of this offal for all human consumption?
       If according to the Minister of Agriculture, it is not a danger, why was it
       banned for babies?

She replied:

       We set up a committee of experts under Professor Southwood. We published
       the report in full. We referred it to the Chief Medical Officer of Health and
       we accepted the recommendations of both, precisely. There is no point
       whatsoever in setting up a committee of experts, in having a Chief Medical
       Officer of Health, in receiving their advice and then not accepting it. We
       would rather accept their advice than that of the hon. Gentleman.

Her Secretary of State for Health would not have been in a position to give a more
informative reply.

552 What of MAFF? Dr Woolfe and Mrs Attridge had directed attention to the
questions raised by the baby food recommendation, and are to be commended for
this. But after the Cabinet meeting the questions were not pursued. We have
concluded that there were a number of officials who should have made sure that the
outstanding questions were answered. First of all, we think that Mrs Attridge
herself, being concerned for composition of food, should have pursued the question
of ‘why should we take action on baby food and not on hamburgers’, which was one
that she had raised earlier. We consider that Mr Cruickshank should have taken
steps to find out why the Southwood Working Party had drawn a distinction
between babies and others, and between clinical and subclinical animals. We think
that Mr Meldrum should have pursued these questions. The former distinction
involved consideration of analogies with matters within the expertise of the
veterinarians, such as the apparent susceptibility of calves to BSE. The latter was
quite plainly a matter of veterinarian expertise.

553 Mr Andrews, the Permanent Secretary, had received a copy of one of the
minutes in which Mrs Attridge raised the question of why action should be taken on
baby food and not other food. He should have raised with Mr MacGregor the need
to have an answer to this question. Mr MacGregor himself had been alerted to
Mrs Attridge’s concerns and should have seen that the question of ‘why babies and
not adults’ was pursued.

554 In short, there was at MAFF, as at DH, a team failure to subject the Southwood
Report to a proper review in order to evaluate whether the unexplained differences
in approach to the food risks posed by BSE had explanations that appeared
to be sound.




                                                                                        109
FINDINGS AND CONCLUSIONS


         The decision to introduce the human SBO ban

         555 In the months that followed the publication of the Southwood Report, a number
         of influences combined to drive MAFF towards the decision to introduce a ban on
         using for human food those types of offal that were most likely to carry
         BSE infectivity.

         556 In the first place there was the public reaction to the Report. This started with
         a broadcast on the day the Report was published from Dr Helen Grant, a consultant
         neuropathologist at Charing Cross Hospital in London, who commented on the risk
         posed by cattle brains that were going into the human food chain. In an article in
         The Guardian on 2 March 1989, she suggested that the Government was
         concentrating on baby food ‘to divert the public from thinking about other foods and
         thus to imply that they are safe, which they are not’.

         557 In May three articles appeared in The Times, suggesting that sausages and meat
         pies were a risk to health and that the Government should ban the use in food of
         potentially infected organs. On 24 May the Woman’s Farming Union issued a press
         release calling for a ban on the inclusion of brain and spinal cord in products for
         human consumption. This theme was taken up the next day by delegates when
         Mr MacGregor attended the Conservative Women’s Conference. On the same day
         the Bacon and Meat Manufacturers’ Association advised its members to exclude
         bovine pancreas, brain, intestine, spinal cord and spleen from their products. The
         Meat and Livestock Commission (MLC), which was being advised by Dr Kimberlin
         (whom we have already met as a witness to the Southwood Working Party69 and a
         member of the Tyrrell Committee and SEAC),70 wrote to Mr MacGregor urging
         him to introduce a general ban on the use of bovine offal for human consumption
         for the sake of public perception.

         558 The Parliamentary Secretary at MAFF, Mr Donald Thompson, had started his
         working life in his father’s butchery business. He told us that he had all along been
         worried about the brains of subclinical animals entering the human food chain.
         In March he made the suggestion that cull cows might be excluded from the human
         food chain. This received short shrift from MAFF officials, but Mr Thompson
         returned to the charge, seeking advice on removing brains and certain other types of
         offal of cull cows from the human food chain, a measure that he subsequently
         supported. We commend him for this.

         559 From the middle of 1988 the pet food industry had begun to address the
         possible infectivity of bovine raw materials incorporated in pet food. In July 1988
         Pedigree Master Foods commissioned Dr Kimberlin to advise on whether their raw
         materials might carry the BSE agent. What he had to tell them they considered to
         have wider significance and they offered to share the information with MAFF. On
         16 May 1989 Pedigree Pet Foods invited Mr Meldrum and other MAFF officials to
         meet Dr Kimberlin. Dr Kimberlin gave Mr Meldrum details of the advice that he
         had given to Pedigree, including the categorisation of offal into four categories
         of risk. The highest was brain and spinal cord and the next consisted of ileum, lymph
         nodes, proximal colon, spleen and tonsil.71 Mr Meldrum told us that it was clear to
         him that Dr Kimberlin thought it a good idea to keep the more infective offal out of
         69
              See para. 255 above
         70
              See paras 286–95 above
110      71
              This was based on studies on the infectivity of the tissues from cases of natural scrapie carried out by Dr William Hadlow
                                                                      PROTECTING HUMAN HEALTH


the human food chain. He left the meeting converted to this viewpoint.
Dr Kimberlin’s analysis had added a huge amount to his knowledge. We wish to
commend Pedigree for their initiative in seeing that this information was provided
to MAFF.

560 Meanwhile MAFF officials had been preparing draft Regulations and a
consultative paper in respect of the proposed ban on offal in baby food. Mr Andrews
warned Mr MacGregor that this would lead to pressure to extend the ban to all
human food. Mr MacGregor was already under pressure in Parliament from Mr Ron
Davies, the Opposition spokesman on Agriculture, to do just this. Mr MacGregor
then met with Mr Meldrum. Mr Meldrum told him of what he had learned from
Dr Kimberlin. This did not persuade Mr MacGregor that the Southwood Working
Party’s assessment of risk was unsound. He told us that what it did was to provide
him with ‘a scientific underpinning for the selection of tissues if Ministers were to
adopt a policy to further reduce the remote risk of transmission of BSE to humans’.
He told us, ‘I had some concern about this. Most of the scientists were telling me
that this concern was unjustified, but there was just beginning to emerge some body
of scientific opinion that there may be something in it, so it had the merit of dealing
with that risk, if there was a risk.’

561 Within days Mr MacGregor had decided to go ahead with a ban. He told us
that his reasons for this decision were:

   •   He wished to reassure the public.
   •   It was easier to introduce a general ban than a baby food ban.
   •   It would deal with any clinical animals that might slip through the net.
   •   It would deal with any risk from tissues from subclinical animals.

562 There was one practical difficulty. It was desirable to get Sir Richard
Southwood’s approval to this course. This called for diplomacy as MAFF proposed
to go beyond the measures that his Working Party had advised.

563 On 6 June Mr MacGregor had a meeting with his officials, to which Dr Jeremy
Metters of DH was invited, in order to prepare for a meeting with Sir Richard
Southwood the following day. Sir Donald Acheson had got wind of what was afoot
and was unhappy about it, fearing that it might raise concerns about the safety of
vaccines. He briefed Dr Metters to resist the move, at least for the time being.
Dr Metters was Senior Principal Medical Officer in DH who had recently become
involved in BSE matters. In August he became Deputy CMO. Dr Metters raised the
concern about the vaccines at the meeting, but reported that this ‘cut little ice’ with
MAFF officials. Mr MacGregor did not refer at the meeting to Dr Kimberlin’s
analysis of the infectivity of tissues in subclinical animals. He left those present with
the impression that his motive for the ban was simply a wish to allay the public
concern which had developed.

564 On the next day the meeting reconvened with Sir Richard Southwood.
Dr Pickles was also present. When told of the proposed ban, Sir Richard made the
point that the scientific evidence had not changed, but accepted the ‘political
necessity for action’. Mrs Attridge then made a suggestion about presentation.
As she reported later:
                                                                                            111
FINDINGS AND CONCLUSIONS


                i.    Professor Southwood maintained his position that there was no
                      scientific evidence to support the belief that offal presented a human
                      health hazard (DOH Dr Metters did not dissent).
                ii.   The Minister maintained his view that presentationally something had
                      to be done to allay public concern.
                iii. The CVO pointed out that the easiest way to ensure any ban was
                     operated was to remove offal (brains, spinal cord, spleen, tonsils,
                     thymus) that were to be covered in the baby food regulations at
                     the slaughterhouse.
                iv. I suggested that the way to proceed was to say that the Minister
                    considered the easier and more enforceable way to implement the
                    Southwood recommendation on baby foods was to remove the offal at
                    slaughterhouses and there it would be dyed and used for fertiliser and
                    that the Minister would thereby not be appearing to contradict the
                    scientific evidence in the Southwood report by taking more
                    comprehensive action than recommended and there would be no
                    need to proceed with consultations under the Food Act.

         565 To those unaware of the potential infectivity of subclinical animals,
         Mrs Attridge’s suggestion on presentation must have seemed attractive. If there
         was no scientific justification for the ban, it would do no harm to suggest that its
         introduction was no more than an administratively convenient way of introducing
         the ban on baby food. The vice of this presentation was, however, that it suggested
         that the ban was unnecessary. It would not encourage those who had to implement
         the ban to take it seriously. Unfortunately, Mr MacGregor agreed to Mrs Attridge’s
         suggestion as to how the ban should be presented.

         566 The presentation of the ban suggested by Mrs Attridge was widely
         disseminated. When Mr Lowson was preparing a briefing for incoming Ministers in
         July after a reshuffle, he included it as the reason for the decision to introduce the
         SBO ban. We were concerned about this, for he did not mention what he thought to
         be the true reason, namely to allay public anxiety as to the risk from subclinical
         animals. But given the pressure of time within which such briefings have to be
         prepared, and their ephemeral nature, we think it would be wrong to criticise
         Mr Lowson’s draftsmanship. Mr Gummer, Mr Maclean and Mr Curry all told us
         that Ministers do not place great weight on such briefings, but Mr Gummer
         subsequently passed on the presentation. At a meeting with UKASTA in October
         1989, and again before the Agriculture Committee in 1990, he emphasised that the
         ban went beyond what the Southwood Working Party had advised was necessary,
         but was introduced as a practical way of giving effect to their baby food
         recommendation. Mr Lawrence included the presentation as the reason for the ban
         in the submission to Mr Gummer that he prepared in November 1989 seeking
         approval of the terms of the draft Regulations. This submission was widely
         circulated within MAFF, DH and the Territorial Departments.

         567 In his press release announcing the ban, Mr MacGregor referred to the
         Government’s undertaking to implement the Southwood baby food
         recommendation. He then added:


112
                                                                      PROTECTING HUMAN HEALTH


          In working out the details, I have concluded that a better way of dealing with
          this would be to ensure that the relevant types of bovine offals should be
          rejected at the slaughterhouses for all cattle so that they cannot be used for
          human consumption in any way . . . This approach also deals with a separate
          problem, namely ensuring that if there is any risk that there are cattle
          incubating the disease but not showing clinical symptoms which are not
          being slaughtered and destroyed, their offals do not enter the food chain
          either.

568 This at least referred to the subclinical animals, but in terms that suggested that
there was no more than a risk that some of these might go for slaughter. In fact this
was inevitably happening on a substantial scale.

569 How far the presentation, which played down the importance of the human
SBO ban, influenced people’s attitudes we shall never know. We had evidence from
many sources, however, of a perception that the ban was not really necessary as a
public health measure. We do not criticise Mrs Attridge for her suggestion, made in
ignorance of the science that underpinned the ban, nor those who repeated what Mr
MacGregor had agreed should be the public presentation of the reason for the ban.
Mr MacGregor is to be commended for introducing a ban which was to prove such
a vital element in guarding against the risk that BSE posed to humans. However, he
should not have agreed to a presentation which played down the importance of the
ban as a protection for human health.

570 One person who thought that the human SBO ban was an unnecessary
precaution was Dr Pickles. She remained of the view that the Southwood Working
Party had recommended all that science justified. She suggested that MAFF should
be left to introduce the ban on its own. Sir Donald Acheson had by now decided,
however, that DH should support the ban. This attitude was shared by Mr Clarke,
although his understanding was that MAFF was motivated by a desire to restore
consumer confidence rather than by any scientific consideration. Mrs Thatcher
approved the ban. She informed us that she did not believe that she would have
accepted the need for the ban solely for public reassurance.

Preparation of the Regulations

571 The ban was announced on 13 June 1989. Five months were to pass before it
was brought into force.72 The Agriculture Committee criticised this delay. We have
considered why it occurred and concluded that it would not be fair to criticise either
MAFF or DH for not moving faster. The ban was introduced under the Food Act
1984 and made use of procedures and mechanisms for dealing with unfit meat that
were already in place under the Meat (Sterilisation and Staining) Regulations 1982
(MSSR). This made good sense, but it carried with it a statutory obligation to
consult. Regulations requiring the removal of tissues from apparently healthy
animals on the ground that a small minority would be incubating a disease that
carried a remote possibility of transmission to humans were novel. They were quite
complex. They carried serious economic consequences for some. We think that
consultation was desirable. What took longer than anticipated was the task of
identifying which offal should be subject to the ban. This was not due to any lack
of diligence, but to the complexity of some of the technical issues that arose. It
72
     We have described the Regulations at paras 386–7 above                                113
FINDINGS AND CONCLUSIONS


         would have been better to have introduced a ban on those tissues which were known
         to be high risk and added to them later by amendment, but that is to use hindsight.

         572 From the outset it was the intention that the ban should apply to brain, spinal
         cord, tonsils, spleen, thymus and intestines, which were recognised as high-risk
         tissues. The principal issues as to the ambit of the ban were whether:

            •   it should include tripe and rennet;
            •   it should include mesenteric fat;
            •   it should include intestines which had been processed to make casings for
                sausages and other meat products;
            •   it should apply to tissues of calves under the age of six months.

         573 Resolving those issues required research, consultation with the industries
         involved and discussion between MAFF and DH. All of this took time.

         574 Mr Bradley, who had been placed in charge of BSE research work at the CVL,
         carried out the research. So far as the first three issues were concerned, his task was
         to ascertain the extent to which lymphoid tissue would remain after the industrial
         processes that were involved. He set about this task with characteristic diligence.

         575 Discussion between MAFF and DH involved Mr Meldrum on the one hand
         and Dr Pickles and Dr Metters on the other. Mr Meldrum’s approach was one of
         reluctance, without good reason, to countenance extending the ban to the detriment
         of established sectors of the food industry. This was a proper approach provided that
         he did not permit concern for the food industry to prejudice the safeguarding of
         public health. We were conscious of accusations that MAFF had done precisely
         that, so we scrutinised this part of the story with particular care. We concluded that
         Mr Meldrum adopted a conscientious and objective approach to his task.

         576 Neither Dr Pickles nor Dr Metters believed that there was any justification for
         the human SBO ban. They saw it as an exercise carried out by MAFF in order to
         improve public confidence in the safety of beef. We were concerned to see whether
         this perception led to any lack of rigour on their part in considering what should and
         what should not be included in the ban. We concluded that it did not. Dr Pickles told
         us that if Ministers, for all sorts of good reasons, wished to do something that was
         not strictly necessary, she would support them. Her aim was to ensure that all the
         bits of offal that might be of concern were removed from the food chain.

         577 Mr Gummer was appointed Minister of Agriculture in July, in the course of
         the preparation of the SBO Regulations. He gave Mr Maclean, one of the new
         Parliamentary Secretaries, special responsibility for food safety. We are satisfied
         that Mr Gummer and Mr Maclean gave careful consideration to the terms of the
         human SBO Regulations. They did not rubber-stamp their officials’ proposals, but
         sought and considered the reasons behind the inclusion or exclusion of various types
         of offal from the ban.

         578 Notwithstanding the diligence that was applied to most aspects of the
         preparation of the SBO ban, it was inevitable that borderline decisions would be
         influenced by the general belief that the ban was being imposed as a measure of
114
                                                                    PROTECTING HUMAN HEALTH


extreme prudence which went beyond the recommendations of the expert scientists.
While those involved made no conscious application of the ALARP principle, the
exercise that they were engaged in entailed weighing perceptions of risk on the one
hand against the economic consequences of banning particular tissues on the other.

579 We turn to record briefly the decisions that were reached as to the ambit of
the ban.

Brain, spinal cord, thymus, spleen and tonsils

580 These ‘high risk’ tissues were intended to be covered by the ban from the
outset. Dr Kimberlin, whose advice was sought by MAFF on the ambit of the ban,
advised that the proposed ban on these tissues was well founded.

Tripe and rennet

581 Rennet was extracted from the abomasum, the fourth stomach of the cow, and
was used for making cheese. One form of tripe was also made from the abomasum.
Concern about these products arose from the fact that the abomasum contained
significantly more lymphoid tissue than the other stomachs. In relation to lymphoid
tissue Mr Bradley proposed a pragmatic test. Lymphoid tissue would be banned
only when macroscopically visible, that is, to the naked eye. On this approach, the
abomasum and its products did not fall within the ban. This approach was approved
by Dr Kimberlin and accepted by Dr Pickles and Dr Metters. Very careful
consideration was given to this issue, which involved a question of nice judgement
as to where the borderline should be drawn. The decision not to include tripe and
rennet in the ban was endorsed by Mr Maclean and Mr Gummer.

Mesenteric fat

582 This was fat that was originally attached to the intestine and which contained
lymphoid tissue. It was excluded from the ban on the basis that, in the course of
processing, the protein containing the BSE agent would fractionate with the solids
rather than with the fat. Similar reasoning had led to the conclusion that tallow need
not be subject to the SBO ban. Ministers initially queried the exclusion of
mesenteric fat from the ban, but on being given this explanation were satisfied
with it.

Casings

583 MAFF officials initially believed that the cleaning of intestines, which were
used as sausage casings, would remove all but an insignificant quantity of lymphoid
tissue and proposed that casings should be excepted from the ban. Dr Pickles
challenged this assumption, whereupon the CVL confirmed that the processing of
sausage casings removed lymphoid tissue. This conflicted with information that DH
had obtained from a medicinal company in relation to the manufacture of sutures
from intestines. Mr Bradley carried out further research, which revealed that
lymphoid tissue remained in casings after processing. Mr Meldrum reported this,
but suggested that casings could be excluded from the ban because they were only
used on black and white puddings, were cooked and were usually discarded at the          115
FINDINGS AND CONCLUSIONS


         table. Sir Richard Southwood and Dr Tyrrell were then consulted, and both
         indicated acceptance of Mr Meldrum’s reasoning. Dr Metters expressed continuing
         reservations, but added that DH was content for MAFF to proceed as it thought fit.
         Mr Meldrum then had second thoughts. He advised Ministers not to exempt casings
         and wrote to Dr Metters explaining: ‘I believe it is most important that we have a
         fully agreed position on this most important area.’ Ministers accepted
         Mr Meldrum’s advice.

         Calves under 6 months of age

         584 There were a number of reasons why Mr Meldrum was anxious to exclude
         offal from calves aged less than six months from the human SBO ban:

            •   It was not slaughterhouse practice to split the carcass of calves, so a
                requirement to remove spinal cord would raise practical problems.
            •   Feed compounders were threatening to boycott SBO-derived MBM.
                An exemption from the ban in respect of calves might discourage them from
                this step.
            •   A ban on SBO from calves would add to the waste disposal problem.
            •   A ban on SBO from calves might provoke export restrictions. The UK had a
                large trade in the export of veal calves.

         585 There were two arguments that could be advanced to justify an exception from
         the ban in respect of the offal of calves:

            •   Calves would have been born after the ruminant feed ban came into
                operation and therefore should not have been infected from feed. The
                weakness of this argument was that it was possible – and Mr Meldrum
                thought it was likely – that calves would be infected with BSE as a result of
                maternal transmission.
            •   Analogy with scrapie research suggested that infectivity would not reach the
                brain or spinal cord of cattle in the first six months of life. This was a cogent
                argument for exempting brain and spinal cord of calves from the ban.
                Dr Kimberlin was, however, concerned that the lymphoreticular system
                (LRS), and in particular the spleen and thymus, might be infective at any age.

         586 Dr Metters indicated that DH could not agree to an exemption in relation to
         calves in the absence of scientific advice justifying this.

         587 Mr Meldrum made enquiries of the trade and was informed that spleen and
         thymus did not enter the human food chain. He passed this information to
         Dr Kimberlin and to Dr Metters, adding that very few calves were slaughtered in the
         United Kingdom each year. Dr Kimberlin then reconsidered the issue and indicated
         that he would be content with an exemption in respect of calves. Sir Richard
         Southwood and Dr Tyrrell were both consulted, and accepted that Mr Meldrum
         had demonstrated valid reasons for an exemption in respect of calves. Finally
         Dr Metters indicated DH agreement to this, adding that the position would have to
         be reviewed if maternal transmission were established. Ministers accepted advice
         that offal from calves should be excluded from the ban.
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                                                                   PROTECTING HUMAN HEALTH


588 The facts that we have outlined above caused us concern. While only
25,000 calves were slaughtered each year in the UK, 250,000 were exported to the
Continent to be slaughtered for veal. Furthermore, thymus, or ‘ris de veau’, was a
prized delicacy on the Continent. In such circumstances, to have sought to disguise
the risk posed by thymus by exempting calves from the ban, with the motive of
protecting our export market, would have been scandalous. We explored our
concerns with the witnesses. Dr Kimberlin assured us that his advice had not been
influenced by export considerations. He also said that he was not overly concerned
about the thymus because scrapie research indicated that thymus was lower risk
than other LRS tissues.

589 Sir Derek Andrews summarised the factors which had satisfied him that the
exemption in respect of calves was justified:

   •   The SBO ban was a measure of extreme prudence.
   •   The risk of transmission to humans was considered remote.
   •   Calves had not been fed MBM.
   •   Scrapie research indicated that calves under 6 months would not contain the
       agent.

590 The evidence we received satisfied us that those involved in the decision to
exempt offal from calves from the ban were not improperly motivated by a concern
to preserve exports and that the exception could be justified on an objective
appraisal of such facts as were known at the time.

Mechanically recovered meat (MRM)

591 We now come to a topic which we have identified as a serious flaw in MAFF’s
precautions to prevent SBO from entering the human food chain. Once all meat had
been removed from the carcass, it was often the practice to subject the bare bones
to the process of mechanical recovery of meat. High pressure was applied to the
bones to separate from them anything that was still adhering. The resultant slurry
was used in a range of meat products for human consumption, including lower grade
sausages, burgers and pies. The major source of bovine MRM was the spinal
column.

592 Spinal cord, together with the brain, was identified as the tissue which
contained the highest titre of BSE infection. It had long been the usual practice in
slaughterhouses for bovine spinal cord to be removed and sent for rendering as part
of the meat-dressing process. That is not to say that it used to be cleanly removed.
We received evidence that before the human SBO ban it was common for sizeable
sections of spinal cord to be left in the spinal column. In that event it would be
sucked out as a constituent of MRM.

593 Once spinal cord was prescribed as an SBO, standards of removal of the spinal
cord in slaughterhouses improved. In 1995, however, it was discovered that
slaughterhouses were, on occasion, leaving small portions of spinal cord attached to
or trapped within the spinal column. We are satisfied that that was a state of affairs
which had persisted ever since the human SBO ban was introduced. Portions
of spinal cord will have gone into MRM.                                                  117
FINDINGS AND CONCLUSIONS


         594 When the human SBO Regulations were being formulated, peripheral nervous
         tissue was believed not to be high risk. Since 1996 experiments have shown one
         respect in which that belief was fallacious. The autonomic nervous system is linked
         to the central nervous system at junction boxes, consisting of clusters of nerve cells,
         alongside each vertebral body. These are known as dorsal root ganglia.73 This tissue
         has now been shown to develop high infectivity between 32 and 40 months after a
         cow is infected with BSE. Dorsal root ganglia will also have been sucked out by the
         MRM process.

         595 On more than one occasion, consideration was given to the question of
         whether it was satisfactory to continue the practice of extracting MRM from the
         spinal column of cattle. Not until late 1995 was it decided that this practice should
         be banned. The first occasion on which the question arose was when the SBO
         Regulations were being prepared.

         596 In June 1989 a minute circulated within MAFF recording that a slaughterhouse
         had given up producing MRM from cattle bones because it could not guarantee that
         all central nervous system (CNS) tissue would be removed from the backbone. This
         did not stimulate any detailed consideration. Views were expressed that the quantity
         of CNS material involved was unlikely to be significant. Mr Bradley responded
         with a warning that the vertebral column might be contaminated with spinal cord
         and commented, ‘Clearly spinal cord must be removed before processing to produce
         MRM should this be allowed to continue.’

         597 The consultation process in relation to the human SBO ban provided further
         warning of the danger that spinal column would be contaminated with residues of
         spinal cord. Some of those consulted responded that total removal of the spinal cord
         was impractical. One pointed out that ‘the residual bone treated hydraulically to
         produce re-claimed meat [would] include spinal cord pieces’.

         598 A meeting was held in MAFF on 27 September 1989 to consider the responses
         to the consultation letter. It was chaired by Mr Cruickshank and attended by, among
         others, Mr Kevin Taylor, Mr David Taylor, Mr Lowson, Mr Lawrence, Mr Maslin,
         Mr Wilesmith, Mr Duncan Fry and representatives from the Territorial
         Departments. Dr Pickles had been given short notice of the meeting and was unable
         to be present. There was no representation from DH. No witness had any
         recollection of what transpired in relation to MRM at this meeting. MAFF’s note of
         the meeting recorded:

                    The proposed ban on specified offals was in itself a measure of extreme
                    prudence, going beyond what Southwood recommended. Though some
                    tissue would be contained in MRM it would be minimal and not present a
                    significant risk. No action should be taken on MRM.

         599 Mr Ron Martin, Deputy CVO at the Department of Agriculture for Northern
         Ireland (DANI), also made a note of the meeting, which recorded the discussion of
         MRM as follows:

                    The possible danger raised by several of those consulted was recognised and
                    during discussion there was an expression of the illogicality of what was
                    being done and, in particular, how easy it would be to have to concede the
118      73
              See the illustration in Chapter 5 of vol. 16: Reference Material
                                                                   PROTECTING HUMAN HEALTH


       possible dangers of material other than those listed in the proposed ban.
       It was agreed not to raise it.

600 The issue of MRM was a complex one. In the following year, as we shall see,
MAFF prepared a paper on it for consideration by SEAC. The amount of work that
went into that paper is illustrative of what was required if the matter was to be
properly considered in 1989. To make a reasoned decision about MRM, it was
necessary to assess:

   •   the amount of spinal cord that might be left attached to the spinal column and
       recovered as MRM; and
   •   the minimum quantity of spinal cord that might be capable of carrying an
       infective dose for humans.

601 Those present at the meeting were not in a position to provide definitive
answers to those questions, but they were in a position to identify that such
questions needed to be addressed. They did not identify them. Part of the problem
appears to have been that no one took on personal responsibility for addressing the
question of whether MRM posed a risk to human health. Responsibility for
producing the human SBO Regulations had been shared. MAFF’s Meat Hygiene
Division had agreed to be responsible for the mechanics of drawing up the
Regulations, but considered that the Animal Health Division had retained
responsibility for policy. It was the Animal Health Division that had charge of
the consultation exercise.

602 Mr Cruickshank said that he relied on the veterinary judgement that MRM was
acceptable. Mr Kevin Taylor said that he had no responsibility for matters relating
to human as opposed to animal health. Mr Lowson said that his divisional
responsibilities were limited to animal health. He also said that the Meat Hygiene
Division had taken the lead in preparing the Regulations. Mr Lowson said he had to
rely on Mr David Taylor, the SVO dealing with meat hygiene issues. Mr Keith
Baker, for whom Mr David Taylor was deputising, told us that it was not for his
section to advise on the implications of infective dose for the safety of MRM.

603 We found this evidence confusing and unsatisfactory, bearing in mind that all
present on 27 September were participating in an exercise that had only one object
– the protection of human health.

604 The decision on MRM depended critically on a combination of knowledge of
the processes of carcass-splitting and removal of the spinal cord; knowledge of the
processes of extracting MRM; knowledge of standards of operation, inspection and
monitoring of abattoirs; and an understanding of what was known, and what was not
known, about infective dose in relation to TSEs.

605 No one before or after the meeting of 27 September set about collecting this
information and presenting it in a form that would enable an informed policy
decision to be taken. There appears to have been a general assumption that, if any
spinal cord were to get into MRM it would do so in quantities too small to represent
a threat. Some failed to appreciate the extent to which spinal cord might get into
MRM. Some seem likely to have made unwarranted assumptions about the
minimum effective dose.
                                                                                        119
FINDINGS AND CONCLUSIONS


         606 Consideration of the proposed SBO Regulations was a team exercise and the
         failure to give rigorous analysis to MRM was a team failure. We believe that this
         failure is explained in large part, and mitigated, by the general belief that the SBO
         ban was a measure of extreme caution that went beyond the recommendations of the
         scientists. In the circumstances it is easy to understand the reaction that if there was
         a failure on occasion to remove a little bit of spinal cord, it was unlikely to matter.
         This does not, however, excuse the failure to carry out the rigorous risk evaluation
         that was required in order to reach a sound decision on policy.

         607 The problem posed by MRM should not have been dismissed at the meeting
         on 27 September 1989. It should at least have been identified as calling for further
         consideration. However, no witnesses could remember any relevant detail as to the
         information or views contributed on this subject at that meeting. It would not, in
         these circumstances, be fair to criticise any individual for the conclusion that was
         reached. Nor would it be fair to criticise those who placed reliance on that
         conclusion. We are simply not in a position where it would be fair to allocate blame
         to any individual for the failure to give rigorous analysis to MRM in 1989.

         608 Dr Metters and Dr Pickles of DH received copies of MAFF’s note of the
         meeting on 27 September. They had no knowledge of the nature of MRM. They
         read the statement that the amount of nervous tissue that it would contain would be
         minimal, and were content with that.

         609 Those who relied upon the outcome of the meeting included Mr Lawrence.
         He advised Mr Gummer that any nervous tissue in MRM would be minimal and that
         the ban should not extend to MRM. Ministers questioned this advice. Mr Maclean
         asked how they could be sure that all abattoirs removed the spinal cord cleanly
         before MRM production took place. Mr Meldrum reassured Ministers that the risk
         from MRM was no greater than that in other cases where an exclusion from the ban
         had been agreed. Mr Meldrum told us that he was not concerned about spinal cord.
         He believed that any fragments would be removed at the dressing stage. He had
         concerns about peripheral nervous tissue, but Dr Kimberlin had provided
         reassurance about this. Mr Meldrum also relied on the conclusions reached at
         the meeting on 27 September.

         610 On this occasion the chance to identify the danger posed by MRM was lost.
         What would have transpired had that danger been identified? We do not think it
         likely that it would have led officials to advise, or Ministers to decide, that the
         practice of extracting MRM from the spinal column of cattle should be banned.
         Mr Cruickshank told us that officials were conscious that the ban went beyond what
         the scientists had advised was necessary for the protection of public health, and
         were apprehensive that action that appeared disproportionate would provoke a
         judicial review. Had the danger of MRM been recognised, we think that this would
         have led MAFF to emphasise to slaughterhouse operators and local authorities that
         it was essential to remove spinal cord in its entirety and to monitor the extent that
         this was achieved once the ban was in force.

         611 In the event, when the ban was introduced, no guidance was given to
         slaughterhouse operators or to the local authorities who had to enforce it. Nor were
         any instructions given to the veterinarians in the VFS, whose job it was to monitor
         the enforcement of the Regulations, that it was important to check that all spinal
120      cord was being removed from carcasses.
                                                                   PROTECTING HUMAN HEALTH


BSE and human health in 1990

612 1990 was an eventful year in the BSE story. It saw a number of practical
problems raised in relation to the implementation of the human SBO ban and the
manner in which government addressed these. It saw restrictions placed on the
export of beef by the EU, and their implications for the United Kingdom. It saw the
natural transmission of BSE to cats, the alarm that this caused, and the response of
government to that alarm. It saw the extension of scientific knowledge about BSE,
with experimental transmission to mice, to cattle and subsequently to a pig.
These latter events led to the introduction of the animal SBO ban, which we have
described in the previous chapter. In this chapter we shall be looking at events that
had relevance to the implications of BSE for human health.

613 In 1990 Mr Gummer completed his first year as Minister of Agriculture,
Fisheries and Food. He had brought with him a new broom. He sought to draw a
clear distinction, within the Ministry, between looking after the interests of the
industry and looking after the interests of the consumer. The former he entrusted to
Mr Curry; the latter to Mr Maclean. As Minister for Food Safety, Mr Maclean
presided over the newly formed Food Safety Directorate. He also chaired a new
Consumer Panel. Mr Gummer made it plain that his Ministry would be following a
policy of openness of information about food safety. He also announced that the
results of all research into BSE would be made public.

614 The same year saw the setting up of SEAC. Mr Gummer was a firm believer
in taking the advice of experts and then following that advice. As soon as SEAC was
set up he began to seek its advice on a wide variety of topics.

Implementation, enforcement and monitoring of the
human SBO ban

615 In the previous chapter we looked at what happened to SBO once it had been
removed from the carcass. This assumed importance in relation to animal health.
There was never any apprehension that, once removed, SBO would find its way into
the human food chain. So far as human health was concerned, the important thing
was that the SBO should be cleanly removed from the carcass without
contaminating the meat.

616 We have already commented on the poor standards of hygiene prevalent in UK
slaughterhouses and the fact that the manner and rigour of enforcement of the
Regulations varied from one local authority to the next.74 Happily these standards
were not generally reflected in the diligence with which the Meat Inspectors set
about their task of ensuring that SBO, and in particular spinal cord, was removed
from the carcass. This was not, however, an easy task. The operation involved
sawing the carcass in half down the backbone with a power saw, thus exposing the
spinal cord, and then removing the cord. It was inevitable that in the process the
spinal cord would sometimes get damaged and that portions of it would remain
trapped or hidden within the vertebrae. It would have needed the most meticulous
skill and care on the part of the Meat Inspectors to make sure that no carcass that
received the health stamp contained any remnants of spinal cord. Skill and care to
that degree was not shown during the period with which we are concerned.
74
     See Chapter 3, para. 389 above                                                     121
FINDINGS AND CONCLUSIONS


         Meat Inspectors were often rushed, and holding up a production line for inspection
         was not popular. No one emphasised that removing all the spinal cord could be a
         matter of life and death, and it was not so regarded. As a result the occasional
         portion of spinal cord would pass through, undetected, with the health-stamped
         carcass, and be destined in many cases to be extracted as MRM.

         617 We have described earlier the monitoring role of the VFS in respect of
         compliance with a large number of Regulations applicable in a slaughterhouse.
         The removal of spinal cord from the carcass was only one of many of the statutory
         requirements that they had to monitor. They were not instructed to give this
         particular attention. On the contrary, insofar as they received instructions, these
         focused on the disposal of the SBO after removal from the carcass, and we had
         evidence that this aspect of the SBO Regulations was the one with which they were
         more concerned.

         618 In these circumstances we can understand why it is that, prior to 1995, there
         is only one recorded occasion on which a member of the VFS identified health-
         stamped meat that contained spinal cord. Only during the national surveillance in
         1995, when unannounced inspections were carried out and when VOs were
         instructed to pay particular attention to the removal of spinal cord, did the fact that
         there were shortcomings in this respect come to light.

         Bovine brains

         619 One slaughterhouse problem that did quickly become apparent after the SBO
         ban was introduced related to bovine brains. Before the SBO ban the head meat
         would normally be removed at a slaughterhouse or head-boning plant, after which
         the head would be sent off with the brain inside to be rendered. Under the SBO
         Regulations a head with brains inside had to be treated as SBO. A practice started
         almost immediately of splitting the skull and removing the brain, so that the head
         could then be despatched, free of regulation, as BSE-free material. This practice
         created an obvious contamination hazard in the slaughterhouse.

         620 No sooner had the ban come into force than Environmental Health Officers
         (EHOs) began to raise with MAFF concerns about the risk of contamination as a
         result of head-splitting and brain removal. There were a number of different
         techniques for splitting the skull and one method of removing brain that avoided this
         was by blasting the brain out of the base of the skull with a high pressure jet of water
         or air. The Institution of Environmental Health Officers expressed concern that all
         methods involved the risk of contaminating the head meat and urged that the
         practice of removing the brain be forbidden. A Liberal Democrat MP, Mr Matthew
         Taylor, took up this cause. MAFF officials took the view that any contamination
         was likely to be too small to worry about. Mr Hutchins, an SVO in the Meat
         Hygiene Veterinary Section, carried out a survey. He advised that there was no
         reason to prohibit the open-skull method of brain removal, although he had
         reservations about the high-pressure method. Mr Gummer was not persuaded, and
         promised Mr Taylor that he would ask an outside expert to consider the matter.

         621 The chosen expert, Mr A M Johnston, expressed reservations about all the
         methods of brain removal and advised that, whenever possible, head meat should be
         removed before any cut was made in the skull. Both Mr Maclean and Mr Gummer
122
                                                                       PROTECTING HUMAN HEALTH


expressed continued concerns about brain removal. Officials reassured them that
draft guidelines on the techniques of brain removal were being prepared which
would reduce contamination to a minimum. The problem was minuscule. The
financial consequences of restrictions would be considerable. None should be
imposed. Ministers were minded to accept this advice, but there followed a further
spate of protests about the practice from many quarters. On 21 May 1989, pressed
about the practice in a parliamentary debate, Mr Gummer stated that it would be
referred for consideration by SEAC.

622 SEAC considered draft guidelines prepared by the Meat Hygiene Division at
their meeting on 13 June and gave them short shrift. They advised that it was not
consistent with common sense to permit the removal of the brain before the head
meat was harvested. Mr Gummer directed that guidelines be issued reflecting this
advice. Mr Meldrum sent them out the following day. They directed that bovine
head meat had to be recovered from the intact skull before the brain was removed.

623 On 10 July 1990 the Agriculture Committee published its report on BSE. One
recommendation was that MAFF’s guidelines on head-splitting should be enshrined
in legislation at an early opportunity. Ministers accepted this recommendation.
On 12 March 1992 Regulations were introduced which:

          i.     prohibited the removal of head meat after the skull had been opened or
                 brain removed; and
          ii.    prohibited the removal of brain in a slaughterhouse or boning plant
                 except in a special area at no time used for food for human consumption.

624 No reasoned application of the ALARP principle was carried out by MAFF.
MAFF officials assumed that contamination would be too minuscule to matter.
Ministers were justified in their reservations about this, and did well to call for
independent advice. SEAC was not an appropriate body to consider technical
questions of head-splitting techniques. It was, however, well qualified to express a
view as to whether risks of contamination from such practices were acceptable.
SEAC did not attempt any quantification of the amount of contamination liable to
result from brain removal. Nor did it weigh in the balance the financial
consequences of the various options. The Committee applied a robust common
sense in assuming that contamination was liable to be significant and advising
accordingly. The outcome was satisfactory. The same cannot be said of SEAC’s
next venture into the world of the slaughterhouse.

Slaughterhouse practices and mechanically recovered meat

625 We have referred to concerns expressed about the removal of spinal cord and
MRM in the course of consultation about the proposed SBO Regulations. These
continued after the Regulations were brought into force. Mr Corbally of the
Institution of Environmental Health Officers expressed the concern of its members
about this. On 18 April 1990 he wrote to Mr Keith Baker:75

          Do you consider that the continued use of mechanically recovered meat from
          bovines is acceptable? . . . MRM could contain significant quantities of
          spinal cord nervous tissue.
75
     Assistant CVO, Meat Hygiene                                                            123
FINDINGS AND CONCLUSIONS


         626 On 21 May Dr John Godfrey of the Consumers in the European Community
         Group, at a meeting with Mr Meldrum and Mr Maclean, questioned whether dorsal
         root ganglia might not be as infectious as spinal cord. Two weeks later, Mr Meldrum
         wrote to Mrs Attridge expressing concern that MRM might be significantly
         contaminated. He told us that it was peripheral nervous tissue that had given rise to
         his concern.

         627 Calls for the banning of the practice of recovering MRM from the spinal
         column of cattle came from:

            •   the Consumers’ Association; and
            •   the MLC Consumer Committee.

         628 Concerns about the practice were expressed to the Agriculture Committee
         from a number of quarters. Of particular note was a submission from Dr Gerald
         Forbes, Director of the Environmental Health (Scotland) Unit, who wrote of MRM:

                Can any guarantee be given that parts of the central nervous system of cattle
                do not enter this product? I would suggest that this is not possible and
                whether or not the practice of producing mechanically recovered meat can
                be considered safe is very much open to doubt.

         629 As we have seen, Mr Gummer decided in May that slaughterhouse practices
         should be referred to SEAC. MAFF set about preparing a paper that would provide
         SEAC with the information that it would need to consider these. The drafting of this
         paper was a major undertaking involving input from the Meat Hygiene Division, the
         Food Standards Division, the Food Science Division, Mr Meldrum and officials in
         the Animal Health Division. The final draft was not produced until October. The
         paper gave SEAC the following information about slaughterhouse practices:

            •   The spinal cord will inevitably receive some damage during carcass-
                splitting.
            •   Inevitably some nervous tissue can remain and some contamination of the
                vertebrae with CNS tissue can occur as a result of:
                     a. small pieces of spinal cord inadvertently remaining in the
                        spinal column
                     b. contamination from carcass-splitting
                     c. the failure to remove nerves from between the vertebrae.

         630 Those responsible for preparing the paper had reached the conclusion that
         some action was called for. Originally they had been prepared to place before SEAC
         a series of alternative options:

                     a. issue guidance to the trade on minimising contamination;
                     b. request local authorities to ensure spinal cord had been removed;
                     c. ban the extraction of MRM from the bovine vertebrae;
                     d. ban manufacture of MRM from bovine carcasses.
124
                                                                   PROTECTING HUMAN HEALTH


Of these, option (c) was to be advanced as the preferred option, coupled with a
recommendation that certain specified research be carried out to ascertain the extent
of the contamination of MRM that was occurring.

631 In the event it was decided not to refer to these options, but simply to ask
SEAC to advise:

       . . . whether any action or guidance is required in relation to slaughterhouse
       practices, and whether any new R&D is needed.

632 What then occurred was this. SEAC members decided that they would visit a
slaughterhouse and see for themselves the procedures involved. Most of them did
so and were given a ‘Rolls-Royce’ demonstration of carcass-splitting and removal
of spinal cord. Those who saw this concluded that spinal cord could be extracted
from the carcass without difficulty. At SEAC’s next meeting, slaughterhouse
practices was one item of an over-charged agenda. SEAC dealt with that item by
advising, in the case of some members on the basis of what they had seen, that so
long as the rules were properly observed and proper supervision was maintained,
there was no need to recommend further measures on grounds of food safety. MAFF
officials and Ministers treated this as reassurance that all was well, and no further
consideration was given to MRM for some years to come.

633 It does not seem that there was any discussion at the meeting about MRM.
Dr Tyrrell suggested to us:

       I suspect that what happened was that we reckoned there was not really
       a problem with MRM if the vertebral column was being cleanly cut
       and dissected.

634 The events that we have summarised demonstrate a serious breakdown of
communication. MAFF officials knew, as their paper expressly stated, that a degree
of contamination of the spinal column with spinal cord was inevitable. Some
members of SEAC, Dr Tyrrell among them, proceeded on the basis that clean
removal of spinal cord was easy and thus something that could be achieved in
practice. It was on the basis of that assumption that they advised that there was no
need for any action. MAFF officials, however, understood that SEAC was
indicating that the degree of contamination described in the paper as ‘inevitable’
was no cause for concern.

635 We do not consider that this sorry story is a matter for individual criticism.
There are, however, lessons to be learned from it. What went wrong?

   •   SEAC had too much on its plate. The agenda did not allow sufficient time
       for a detailed discussion of MAFF’s paper on slaughterhouse practices.
   •   The advice sought from SEAC was not targeted. SEAC’s expertise lay
       not in slaughterhouse practices but in the potential consequences of
       consumption of spinal cord. As we shall see, the Committee had been
       considering infectious dose for the purpose of advising the CMO. It based its
       advice not on this consideration, but on its conclusion about slaughterhouse
       practices. SEAC should have been asked expressly whether the
       contamination described in MAFF’s paper was cause for concern.
                                                                                        125
FINDINGS AND CONCLUSIONS


              •    SEAC was not informed of the options which MAFF officials had identified.
                   We consider that it would have been helpful if SEAC had been told
                   about these.
              •    SEAC was unaware of the concerns that had been expressed about the
                   removal of spinal cord and the safety of MRM.

         636 Had SEAC been aware of all these matters, we think it likely that it would have
         endorsed the suggestion that further research be carried out in order to quantify the
         amount of spinal cord material getting into MRM. This might have led to SEAC
         endorsing the further option of recommending a ban on the extraction of MRM from
         the bovine vertebrae. There can be no certainty that it would have done so.

         637 Had MAFF officials been left to advise Ministers unaided by SEAC, we think
         it likely that they would have recommended option c) of those they had identified,
         as set out in paragraph 630 above. If not, they would surely have recommended
         options a) and b). It was unfortunate – and possibly tragic – that the intervention of
         SEAC should, as a result of a breakdown of communications, have left MAFF
         officials and Ministers falsely reassured about the safety of MRM.

         Europe and lymphoid tissue

         638 The slaughter and compensation policy and the human SBO ban protected
         consumers of beef products in both the United Kingdom and countries to which
         these were exported. The European Commission decided, however, to take
         additional measures to protect Continental purchasers of British beef. These
         included a requirement76 made in June 1990 that the UK should certify all boneless
         beef for export to other Member States as being ‘fresh meat from which during the
         cutting process obvious nervous and lymphatic tissue has been removed’.

         639 MAFF carried out a survey to discover the extent to which the cutting
         procedures employed in UK plants satisfied this requirement. It was discovered that
         the procedures varied widely from those plants which removed virtually all lymph
         nodes to those which removed very few. Alarmingly, ‘healthy’ lymph nodes which
         had been removed were used in meat products for human consumption or rendered
         for either human food or animal feed.

         640 Consideration was given to legislating to add lymph nodes to the list of SBO.
         There were, however, intractable problems with such a course. Not all lymph nodes
         could be prescribed, for they were to be found throughout the carcass. It would not
         be practicable to have Regulations which prescribed ‘obvious lymphatic tissue’, for
         this would lack certainty. Furthermore, lymph nodes were often not removed until
         meat was being dressed in the butcher’s shop, and it would be difficult to devise
         Regulations that would cover that situation.

         641 In the event it was decided to issue guidelines, designed both to enable the UK
         to comply with the EC Decision and to set a common standard for beef, whether it
         was to be consumed in the United Kingdom or exported.



126      76
              Introduced by European Commission Decision 90/261/EC
                                                                      PROTECTING HUMAN HEALTH


642 On 16 June guidelines were issued which provided that:

          All lymphatic and nervous tissue that is exposed during normal cutting
          operations must be trimmed off, so that such material is not visible on the cut
          surfaces of the meat.

          Lymphatic and nervous tissue that is removed must not be used in meat
          preparations or products that are intended for human consumption.77

643 We consider that the response to the Commission Decision was reasonable. It
had, however, one consequence which we do not believe was appreciated. Because
lymphoid tissue was not brought within the definition of SBO, it continued to be
available for rendering for animal feed after the animal SBO ban was introduced.

Alarms and reassurances

644 We now turn to a quite different topic, one of great interest to our Inquiry –
the communication of risk to the public. By 1990 BSE had been transmitted to a
number of different species – for the most part experimentally. Transmission
naturally, through feed, had occurred in a number of exotic species in zoos. The
range of species in which transmission had occurred was wider than that observed
with scrapie. These transmissions were, to put it neutrally, consistent with the
possibility that BSE was transmissible to humans. Few put it neutrally, however.
The media, focusing on the comments of some independent scientists, were quick
to draw the conclusion that instances of cross-species transmission demonstrated
that humans were at risk. Government officials were at pains to emphasise that
experimental conditions were not reproduced in nature and that no implications as
to human risks could be drawn from transmission to animals. Reassurances were
given about the safety of beef. The Meat and Livestock Commission (MLC)
regarded its principal role as the support of the meat and livestock industry. The
MLC was particularly assiduous in seeking to counter the suggestion that it might
be dangerous to eat beef. Regrettably this enthusiasm led on occasion to statements
which were not scientifically correct.

645 In January, The Independent quoted scientists at the NPU acknowledging a
‘remote possibility’ that BSE might move from cows to people, and the comment
from one of them that nothing would induce him to eat sweetbreads, spleen or brain.
‘A human would have to eat an impossible amount of pure cow brain at the height
of infection’ to reach an equivalent dose to that needed to infect a cow, riposted
Mr Colin Maclean, Technical Director of the MLC. He should have resisted this
absurd exaggeration.

646 By this time Professor R M Barlow at the Royal Veterinary College had
succeeded in effecting oral transmission of BSE to mice, and preliminary results of
experiments at the CVL had demonstrated that inoculation of cattle with BSE-
infected material had transmitted the disease. MAFF delayed making public the
results of the mouse experiment until 1 February 1990 for presentational reasons.
They considered it essential for the results of both sets of experiments to be
announced at the same time. MAFF’s press release received consideration by
Mr Andrews and by Mr Gummer. It included this comment:
77
     YB90/6.14/3.3                                                                          127
FINDINGS AND CONCLUSIONS


                   The BSE results therefore provide further evidence that BSE behaves like
                   scrapie, a disease which has been in the sheep population for over two
                   centuries without any evidence whatsoever of being a risk to human health.

         Thus the first oral transmission of BSE to another species was presented as
         reassuring. Not everyone found it so. An official who visited the NPU in
         January reported:

                   The researchers I spoke to are obviously very troubled about the ability of
                   this disease to jump species. If it can be passed from cattle to mice, then what
                   about humans?78

         The press contrasted MAFF’s statement with views expressed by Dr Helen Grant,
         Consultant Neuropathologist:

                   My gut feeling is that some genetically susceptible people may have become
                   infected with material by eating meat products.

         647 From March 1990 the media began to give prominence to the views of
         Professor Richard Lacey, a Professor of Clinical Microbiology at Leeds University.
         Today reported him as predicting:

                   In the years to come our hospitals will be filled with thousands of people
                   going slowly and painfully mad before dying.

         648 In April Humberside County Council banned beef from school meals.
         Other local authorities were to follow their example. Then came the cat.

         The cat

         649 On 6 May 1990 officials at MAFF and DH reported to their Ministers that
         Bristol University had diagnosed a ‘scrapie-like’ spongiform encephalopathy in a
         domestic cat. Here was a bombshell. The public was likely to conclude that the cat
         had caught BSE from eating contaminated beef. And if this could happen to a cat,
         why should not human beings suffer the same fate? Yet it was far too soon to jump
         to any such conclusion. It was possible that there had always been the occasional
         case of feline spongiform encephalopathy (FSE) which had gone unrecognised.
         Nonetheless, if a cat had caught BSE from food, it was cause for concern. CJD had
         been transmitted experimentally to a cat by inoculation, but attempts to transmit
         scrapie had not succeeded. Here was an indication that BSE might be more virulent
         than scrapie.

         650 On 10 May Mr Gummer and Mr David Maclean, the Parliamentary Secretary,
         met with officials to discuss how to make public the news of the cat. A note of the
         meeting prepared by Mr Gummer’s Principal Private Secretary recorded that
         Mr Meldrum ‘confirmed the Minister’s assumption that there was no likely
         connection between this case and BSE’. We have already noted (paragraph 363)
         that there was no basis for this degree of reassurance and Mr Meldrum should have
         been more cautious.

128      78
              YB90/1.9/3.1
                                                                    PROTECTING HUMAN HEALTH


651 Mr Meldrum found himself under pressure from the media to comment on the
implications of the cat. He emphasised that this was the first known case of FSE and
that there was no known connection with other animal encephalopathies, but that
investigations into the case were continuing. The risk to humans was no greater than
before the diagnosis; the cat was no cause for concern.

652 We think that Mr Meldrum played down the potential significance of the cat
more than an objective appraisal would have justified. But he no doubt had in mind
the part played by the media in previous ‘food scares’, such as salmonella in eggs
and listeria, and was seeking to counter extreme statements about the implication of
the cat which went much further than justified on what was then known. In the
circumstances we do not think it would be fair to criticise him for his defensive
public stance.

653 Intense media coverage followed. The Sun published an article stating that
BSE could be the biggest threat to human health since the Black Death plague.
British beef was reported to have been banned in Russia and in schools up and down
the country. Professor Lacey called for the slaughter of every herd with a case
of BSE.

654 Again the MLC leapt into the breach with too much vigour. Mr Colin Maclean
was responsible for the text of a video to be distributed to local authorities which on
one reading erroneously suggested that it would be necessary to eat an impossible
amount of brain and spinal cord in order to be at risk. In a press release he stated
that ‘even if no further action had been taken following the outbreak of the disease
there was considered to be no risk to consumers from eating beef’. We do not
believe that Mr Maclean intended to mislead, but both these statements were
capable of doing so. We think that he should have been more careful.

655 Of more importance were the official statements. MAFF issued two press
releases on 15 May, for the terms of which Mr Gummer was himself responsible.
These were directed to the safety of beef. Mr Gummer made unequivocal statements
that it was safe to eat beef, but he made it plain that he did so on the basis that the
slaughter and compensation policy and the SBO ban provided protection for the
consumer against any remote risk which might otherwise exist. This qualification
was vital and, in the light of it, we would not criticise these press releases.

656 The following day, BBC Newsnight featured television footage of
Mr Gummer attempting to feed his four-year-old daughter Cordelia a beefburger.
We understand that Mr Gummer had been challenged by a newspaper to
demonstrate his confidence in beef in this way. Mr Gummer was faced with
choosing between two unattractive alternatives. It may seem with hindsight that,
caught in a ‘no win’ situation, he chose the wrong option, but it is not a matter for
which he ought to be criticised.

657 Sir Donald Acheson was pressed by MAFF to add his reassurance that it was
safe to eat beef. His press officer told him that, having regard to the media pressure,
it was essential that he should make a statement. He managed to discuss the terms
of his statement with three members of SEAC – Dr Tyrrell, Dr Will and
Dr Kimberlin. He then issued the following press release on 16 May:

                                                                                          129
FINDINGS AND CONCLUSIONS


                I have taken advice from the leading scientific and medical experts in this
                field. I have checked with them again today. They have consistently advised
                me in the past that there is no scientific justification for not eating British
                beef and this continues to be their advice. I therefore have no hesitation in
                saying that beef can be eaten safely by everyone, both adults and children,
                including patients in hospital.

         Later, in a television interview, he stated that ‘there is no risk associated with eating
         British beef’.

         658 Sir Donald told us that when he learned of the cat he ‘remained deeply
         concerned about the possible implications of a further ‘transpecies “jump” of BSE’.
         He told us that his statement about the safety of beef was made, as were
         Mr Gummer’s, ‘on the confident assumption that the SBO ban was already
         fully implemented’.

         659 In contrast to the press statements made by Mr Gummer, Sir Donald’s
         statement did not explain that his confidence in the safety of beef was premised on
         the removal of all SBO. It gave no indication of any concern about the cat. It was,
         we feel, a statement that was likely to convey the message not merely that ‘beef is
         safe’, but that ‘BSE is no risk to human health’.

         660 We do not consider that, as Chief Medical Officer, Sir Donald should have
         restricted his public statement in the way that he did. The development of a
         spongiform encephalopathy in a cat had raised a concern that BSE might be
         transmissible in a way that scrapie was not. Sir Donald was in no position to allay
         that concern. He avoided addressing it by limiting his statement to the safety of beef.
         He did not explain that he considered beef safe only because the parts of the cow
         that might be infective were being removed from the food chain. His statement was
         likely to give false reassurance about the possibility that BSE might be transmissible
         to humans and we think that he should have appreciated this. The possibility that
         BSE might have been transmitted to a cat was cause for concern and needed to be
         investigated by the scientists. He should have explained that he believed that beef
         was safe to eat because of the precautionary steps that had been taken to guard
         against the possibility that BSE might be transmissible in food.

         661 Sir Donald’s unqualified statement that it was safe to eat beef was to set
         a pattern. Public concerns about the dangers arising from BSE were met by
         statements limited to giving assurance that it was safe to eat beef. Members of the
         public tended to equate those statements with assurances that BSE posed no risk to
         humans. It was natural that they should do so. It is no wonder that when, on
         20 March 1996, the Government announced that there was probably a link between
         BSE and vCJD, many felt that they had been deceived.

         The Agriculture Committee

         662 On 16 May 1990 the public concern generated by the cat led the Agriculture
         Committee of the House of Commons to institute an inquiry into BSE. Over a
         period of just over a month an impressive body of evidence, both oral and written,
         was received. The Committee reported on 18 July. The Committee observed that
         while scientists believed that there were too many unknowns to say anything about
130
                                                                        PROTECTING HUMAN HEALTH


the disease with absolute certainty, no evidence had been forthcoming that it did
pose a risk to human health. It concluded:

           The Government has already acted to cut off the presumed source of the
           disease in cattle and has banned the sale of all specified cattle offals for
           human consumption. We believe these measures should reassure people that
           eating beef is safe.

           If the ban on the sale of specified cattle offals for human consumption
           is properly policed in slaughterhouses, full public confidence can
           be maintained.

SEAC considers the safety of beef

663 At the request of Sir Donald Acheson, SEAC held an emergency meeting on
17 May 1990 to consider the implications of the cat. Sir Donald had hoped that
SEAC would produce a letter endorsing the statement that he had made about the
safety of beef. At their meeting the Committee members found themselves unable
to agree on the terms of this. Not until 24 July were they able to give final agreement
to the terms of a letter to the CMO and an accompanying annex dealing with the
safety of beef.

664 There were unsatisfactory features both about the manner in which these
documents were prepared and about the terms in which they set out SEAC’s advice.
The letter set out briefly the reasons for SEAC’s conclusion that:

           In our judgement any risk as a result of eating beef or beef products is
           minute. Thus we believe that there is no scientific justification for not eating
           British beef and that it can be eaten by everyone.

The annex spelt out in greater detail the reasons for that conclusion.

665 The origin of the annex was a paper that Dr Pickles had prepared to brief the
CMO before his appearance before the Agriculture Committee. She explained
to him:

           The arguments are those that have or should have been discussed by the
           Tyrrell Committee [ie, SEAC].

666 It was subsequently adopted by SEAC as the basis for their advice to the CMO.
The draft annex was, however, circulated widely by Dr Pickles and Mr Lowson
within DH and MAFF, so that officials could suggest amendments to the draft.
Mr Thomas Murray79 of DH expressed concern that ‘the Annex will give us
considerable presentational problems and do little/nothing to reassure the public
about the safety of British beef’. In MAFF it was forwarded to Mr Gummer and
Mr Maclean for approval, but only after a process which had led Mr Lowson to note
that ‘the most inflammatory pieces of drafting in earlier versions have now been
edited out’.


79
     Head of Section, Environmental Health and Food Safety Division                           131
FINDINGS AND CONCLUSIONS


         667 We were unhappy about this editorial process. It seemed to us that there might
         well be a conflict between officials’ desire that the annex should not contain
         inflammatory matter and the desirability that the annex should fairly and objectively
         summarise SEAC’s views on risk.

         668 Dr Tyrrell accepted that, had there been time, it would have been preferable
         for the Committee to have formulated its own view, but defended what had occurred
         because SEAC was under time constraints. We do not believe that the editorial
         process resulted in any distortion of SEAC’s views, but remain of the opinion that
         it would have been preferable if the Committee had been left to do its own editing
         of the draft annex.

         669 We turn to the substance of SEAC’s advice. The passages that gave us concern
         were those that dealt with dose. The question of the amount of infective material
         that might suffice to transmit the disease was of practical importance when
         considering the precautions that needed to be taken against transmission, whether
         to other animals or to humans. SEAC commented more than once that ‘very large
         doses’ were needed for oral transmission. The Committee members explained to us
         that they were speaking of the titre of infectivity, not the quantity of physical
         material that held the dose. Once this was explained, we could follow SEAC’s
         reasoning. Nonetheless, we felt that the language that they had used tended to
         suggest that they were speaking of the amount of infective material. Here is
         an example:

                . . . the incubation period in mice was longer after large oral doses of BSE-
                infected cattle brain than after much smaller parenteral injections – in these,
                as in other animal experiments, large doses appear to be needed for
                successful disease transmission.

         670 SEAC submitted to us that the letter and its annex were prepared for the CMO
         and would have been likely to circulate among readers who were familiar with the
         concept of dose. We accept that point and have concluded that it would not be right
         to criticise SEAC for the language used. We believe, however, that the annex was
         circulated within MAFF and fear that it may have given rise to misunderstanding.
         The evidence shows that in 1990, and indeed for some years thereafter, there was a
         perception on the part of many within government that a substantial quantity of
         infective material would be required orally to transmit BSE to a cow and that the
         same would be true of transmission from cow to human, if indeed such transmission
         was possible. It is at least possible that SEAC’s annex contributed to this belief.

         A look ahead

         671 In the period up to 1990, MAFF had taken the lead in addressing the possibility
         that BSE posed a risk to the safety of human food. Although Dr Metters and
         Dr Pickles had played a diligent role, albeit a secondary one, in considering which
         tissues should be included in the human SBO ban, they had done so in the belief that
         the ban was not scientifically justified.

         672 The attitude of Dr Metters at this time was demonstrated by a response that he
         sent in October 1990 in answer to a suggestion by Mr Murray that DH should ensure
         that a continuous flow of appropriate BSE information should be sent to Directors
132
                                                                                                     PROTECTING HUMAN HEALTH


of Public Health, Consultants in Communicable Disease Control and
Environmental Health Officers. Dr Metters wrote that he was concerned that
such activity might raise the implication that:

           . . . somehow the disease poses a risk to human health. Every effort has thus
           far been made to underline the Government’s position, based on advice from
           the Southwood and Tyrrell Committees that the disease is not a risk to
           humans. That principle lies behind this Department’s low-key approach
           to publicity.

Dr Metters should not have given this response, which seems to us to convey quite
the wrong message.

673 In the years ahead DH continued to play a subordinate role in addressing the
food risks relating to BSE – so much so that, in the final days before 20 March 1996,
it did not occur to Mr Hogg and Mrs Browning that Health Ministers should even
be consulted about appropriate measures to enhance the protection of human health.

674 The first case of FSE was not merely of concern to the general public. It was
of concern to SEAC. The Committee was unable to draw conclusions without
knowing whether the cat had contracted the disease from BSE. It advised that there
was an urgent need for research. In due course, as the number of cases of FSE grew,
it became accepted that they had probably caught the disease from eating bovine
offal infected with BSE. Mr Meldrum commented in evidence to us that no specific
observations or recommendations were ever made on the effect of FSE on the risk
to humans. In this he is correct. We had evidence from a number of scientists that
transmission of BSE to cats was an event which altered their belief that BSE posed
no greater risk to humans than scrapie. The public were never told that scientists’
appraisal of that risk had changed. On each occasion that public concerns were
raised about BSE, they were met with the same refrains – ‘There is no evidence that
BSE is transmissible to humans’; ‘It is safe to eat beef’. Risk communication in
relation to BSE was flawed.



The false peace – 1 January 1991 to 31 March 1995

675 In this section we take the story on to 1 April 1995, when the national Meat
Hygiene Service (MHS) took over the enforcement of slaughterhouse Regulations
from the local authorities. This was a watershed event in the BSE story. It led to
discovery of the scale of the inadequacies of the implementation and enforcement
of the animal SBO ban. This we have described in Chapter 5. It led to the discovery
of shortcomings in the clean removal from the carcass of all spinal cord. This we
shall consider in the next section. This section covers a period of relative inactivity
in the BSE story.80

676 We shall begin with a short description of the hygiene standards in
slaughterhouses that led to the setting up of the MHS. We shall also describe
shortcomings in the regulatory structure which the MHS inherited. These are of
80
     Changes in the MAFF and DH teams during this period included the following: Mrs Gillian Shephard succeeded Mr Gummer
     as Minister of Agriculture, Fisheries and Food on 27 March 1993 and she, in her turn, was succeded by Mr William Waldegrave
     on 20 July 1994. Mr Richard Packer succeeded Sir Derek Andrews as Permanent Secretary at MAFF on 17 February 1993.
     In DH Mr Waldegrave was succeeded as Secretary of State in 1992 by Mrs Virginia Bottomley, and Dr Kenneth Calman took
     over from Sir Donald Acheson as CMO in September 1991                                                                         133
FINDINGS AND CONCLUSIONS


         relevance in helping to understand why there were failures in implementing and
         enforcing the obligations to remove spinal cord. They also explain the much more
         serious inadequacies in the handling of SBO once it had been removed, which we
         have looked at earlier in this volume. We shall, in addition, describe briefly the
         political process which led to the setting up of the MHS.

         677 Next we shall look at the evidence relating to monitoring of the human SBO
         Regulations up to April 1995, and at some further consideration that was given to
         MRM. We shall note an important amendment to those Regulations.

         678 During this period knowledge about BSE advanced as results began to be
         received from the research projects that had been undertaken. We shall consider the
         extent to which this knowledge was communicated to the public. Events which
         caused concern to the public, and to government, were the incidence of two cases
         of CJD in dairy farmers and the first case of a teenager to suffer from this disease.
         We shall look at the media reaction to these events and the official response.

         Slaughterhouse standards

         679 In an era of deregulation, a convincing case had to be made out for
         the introduction of the centralised MHS. Standards of hygiene in British
         slaughterhouses provided that case. Mr Gummer gave this vignette to the House of
         Commons Agriculture Committee in October 1992:

                ‘Slaughter hall floor heavily soiled with blood, gut contents and other debris
                – no attempt to clean up between carcasses. Car cleaning brush heavily
                contaminated with blood and fat being used to wash carcases. Knives and
                utensils not being sterilised. Offal rack and carcase rails encrusted with dirt.
                Missing window panes in roof – birds, flies and vermin entering’. Another
                slaughterhouse report: ‘Filthy equipment and surfaces – congealed and dry
                blood on offal racks. Effluent discharging across floor under dressed
                carcasses – risk of contamination. Slaughterman at cattle sticking point not
                sterilising knife. No sterilisers to wash basins in pig slaughter hall. No fly
                screening on open windows’.

         680 The previous year Mr Gummer had reported to the Prime Minister that
         60 per cent of red meat slaughterhouses did not meet European standards. Many
         plants recorded as satisfactory were only just acceptable. On the introduction of the
         Single European Market on 1 January 1993, 544 British slaughterhouses sought a
         temporary derogation from compliance with European hygiene requirements. When
         EU Veterinary Inspectors carried out surveillance of these establishments in 1994,
         they found that 68.5 per cent were of concern or of grave concern.

         681 MAFF officials initially had little knowledge of how local authorities set about
         complying with their obligations to enforce Regulations in slaughterhouses. In 1992
         Mr Lawrence was appointed to lead an MHS Project Team to investigate this.
         He discovered an unsatisfactory state of affairs. There were instances of animosity
         between plant management and Inspectors, and between Official Veterinary
         Surgeons who oversaw enforcement, usually under contract, and the Inspectors and
         EHOs on the staff of the Environmental Health Departments of the local authorities.
         In many cases there was an unclear management chain and lack of teamwork.
134
                                                                    PROTECTING HUMAN HEALTH


682 In January 1992, Mrs Jane Brown, Head of Meat Hygiene Division, forwarded
a paper to the Cabinet Office as a basis for discussion by officials of the proposal to
create a national Meat Hygiene Service. This recorded:

       The State Veterinary Service, who monitor standards, have no real control
       over LAs. The Official Veterinary Surgeon . . . has little real management
       control over the meat inspectors in the plant . . . standards of enforcement are
       uneven across the country.

683 A review in 1992–93 of hygiene standards in a sample of slaughterhouses
confirmed this picture and commented: ‘In many cases, the Local Authority
appeared disinterested.’ Many witnesses gave evidence to us to similar effect.

684 We asked MAFF officials whether evidence of poor hygiene standards in
slaughterhouses did not raise concerns about the standard of enforcement of the
duty to remove spinal cord from the carcass. Each replied that it did not. Some
commented that they had imagined that this was a simple operation. Others said that
removal of unfit meat from the carcass was so important that they believed Meat
Inspectors gave priority to strict enforcement of that obligation.

685 We were at first inclined to believe that poor standards of general hygiene
would inevitably go hand in hand with poor standards of compliance with the SBO
Regulations. So far as concerned the formalities of disposal of SBO once it had been
removed from the carcass, we were proved right. Standards of removal of spinal
cord do not, however, appear to have reflected the poor standards prevailing
elsewhere in the slaughterhouse. After the MHS took over, inspections disclosed
that failure to remove all spinal cord before meat was health-stamped had probably
been occurring on average in four cases out of a thousand. Although this level of
failure was not satisfactory, it suggests that in general the operation of removing the
spinal cord was carried out efficiently and effectively. The occasional failure to
remove all the spinal cord had been described in MAFF’s paper to SEAC in 1990
as inevitable. Under the structure in place before the MHS took over we believe that
it was. After the MHS was in place, by adding resources and monitoring a campaign
aimed at ensuring 100 per cent removal of spinal cord, MAFF and the MHS appear
to have come close to achieving this goal.

History of the setting up of the Meat Hygiene Service

686 In July 1991 Mr Gummer wrote to Mr Waldegrave, who was at that time
Secretary of State for Health, to propose the setting up of what was to become the
MHS. Mr Waldegrave replied that he was ‘content’ with the proposal. In November
the proposal was placed before the Prime Minister, who wished to know the reaction
of the Treasury. Mr Mellor, Chief Secretary to the Treasury, at first had
reservations, but those were dispelled and Mr Major announced on 9 March 1992
that a new Meat Hygiene Service was to be set up.

687 The decision proved controversial. When the Conservative Party was returned
to office after the General Election with a greatly reduced majority, there was back-
bench opposition from its own MPs to the need for additional hygiene measures.
Many, including the meat industry, major retailers and some journalists, considered
                                                                                          135
FINDINGS AND CONCLUSIONS


         that MAFF was going too far in pandering to what they saw as European
         over-regulation.

         688 When Mrs Shephard succeeded Mr Gummer, she took a fresh look at the
         proposal for the MHS. Although she had initial misgivings, she was persuaded by
         her officials that it was an essential measure. She ran into opposition, however, from
         Mr John Redwood, who had been appointed Secretary of State for Wales. In
         October 1993 Mr Michael Portillo, who had been appointed Chief Secretary to the
         Treasury, also suggested that she should look again at the proposal. Mrs Shephard
         stood firm, supported by Mr Ian Lang, Secretary of State for Scotland. The
         following month Mr Redwood and Mr Portillo indicated their acceptance of
         the project.

         689 In 1994 the work of establishing the MHS proceeded. Mr Johnston McNeill
         was appointed Chief Executive. The new Agency was to inherit the staff in the case
         of 176 of the local authorities; their existing terms and conditions differed and had
         to be renegotiated in each instance. In July 1994 Mr Waldegrave succeeded
         Mrs Shephard as Minister of Agriculture. Once again he satisfied himself of the
         merits of the scheme. The MHS replaced the local authorities on 1 April 1995.

         690 The establishment of the MHS was not a measure taken in response to the
         emergence of BSE. Accordingly it has not fallen within our terms of reference to
         consider why so long elapsed between the decision to introduce the Service and the
         implementation of that decision. The establishment of the MHS had a beneficial
         impact on the implementation of both the human and the animal SBO ban. It is
         unfortunate that this was so long delayed.

         Monitoring compliance with the SBO Regulations

         691 In Chapter 5 we saw how monitoring of the SBO Regulations in
         slaughterhouses was intensified between 1991 and 1995. This was, however, in
         response to concerns about the animal SBO ban. The instructions received by the
         Veterinary Field Service (VFS) required it to concentrate on the handling of SBO
         after removal from the carcass. The focus of attention was the gut room, not the
         ‘clean’ side of the slaughterhouse. The only specific question on the SVS pro forma
         covering slaughterhouse visits that related to human health asked whether removal
         of bovine brains involved contamination risk. There was no mention of spinal cord.

         692 Records of slaughterhouse visits have been lost for large parts of the period
         between 1991 and 1995. In 1990 there had been one report of a failure to remove
         spinal cord from the carcass. That is the only such report of which we are aware.
         Apart from a few early reports about brain removal, there was nothing to suggest
         that slaughterhouse operations involved any risk to human health.

         693 We have already discussed why it was that the VFS did not discover the
         deficiencies in compliance with the Regulations in the gut room until after the MHS
         had taken over. The same reasons apply in relation to the removal of spinal cord.
         We believe that the principal reason was the difference in rigour of the inspections
         before and after the MHS took over.

136
                                                                    PROTECTING HUMAN HEALTH


694 Mr Christopher Clarke, who had served as a Meat Hygiene Inspector, told us
that it was typical for MAFF Veterinary Officers on their periodic inspections
to arrive mid-morning and depart a few hours later, after discussion with the
management of the plant and the principal Environmental Health Officer. Such a
visit was unlikely to detect the occasional failure to remove a segment of spinal
cord, particularly if the focus of the visit was what was taking place in the gut room.

695 It may well be that there was, on occasion, a lack of diligence on the part of
the Veterinary Officer making the monitoring visit. It was regrettable that the need
to give specific instructions to monitor the removal of spinal cord was not identified
when the Regulations were being introduced and particularly unfortunate that, when
SEAC was asked to look at slaughterhouse practices, its response was understood
to signify that these were not cause for concern. We have no criticism to make of
Mr Hutchins, Mr Simmons or their superiors in relation to this aspect of the
monitoring duties of the SVS.

MRM on the agenda again

696 On 8 April 1994 Mr Meldrum called a meeting of MAFF officials to review
arrangements for disposal of SBO. Although the primary concern seems to have
been enforcement of the animal SBO ban, Mr Meldrum suggested that ‘one way to
increase security would be to prohibit the use of spinal column for MRM’. Impetus
was given to this suggestion when, in July, the European Commission’s Scientific
Veterinary Committee recommended that vertebrae from cattle killed in the UK
should no longer be used for the production of MRM. This recommendation was not
pursued, but MAFF prepared a paper on MRM for SEAC to consider at its meeting
on 30 August 1994. The Committee was asked to advise on the use of spinal column
for the production of MRM. Not for the first time SEAC had a heavy agenda, and
this item was deferred, to be restored in June the following year.

The distal ileum of calves

697 One experiment carried out by the CVL81 involved feeding calves with BSE-
infected brain and then slaughtering an animal every four months (after the first two
months had passed) and testing 44 tissues for infectivity by injecting them into the
brains of susceptible mice. In June 1994 a positive result was obtained from the
distal ileum (small intestine) of a calf slaughtered only six months into the
experiment. This was an event of some significance. Hitherto only brain and spinal
cord of BSE victims had been found to be infective. Furthermore, tissues from
calves of less than six months of age had been excluded from the SBO ban.
MAFF Ministers and officials were informed of the result and Mrs Bottomley,
the Secretary of State for Health, was informed the same day.

698 It was agreed between the two Departments that SEAC’s advice should be
obtained before this experimental result was made public. An ‘exceptional meeting’
was called on 25 June 1994. SEAC expressed the view that any risk to humans from
food derived from calves was minuscule, but added that it was not possible to give
a definitive answer:


81
     The pathogenesis experiment                                                          137
FINDINGS AND CONCLUSIONS


                There is a theoretical risk and Government could respond by a limited SBO
                ban for calves to exclude the intestines.

         699 Over the weekend Mr Meldrum and MAFF officials held lengthy meetings
         with Dr Calman, the CMO. Dr Calman said that he would be advising Ministers that
         the distal ileum and thymus of calves should be proscribed as SBO. Those present
         agreed with his conclusion. Officials met with MAFF Ministers the next day. The
         point was made that the proposed ban would have a serious effect on the export of
         calves and have a knock-on effect on the price of beef. Mrs Shephard responded that
         where public health was concerned, trade was the least important consideration.
         She later met with Dr Calman to discuss the terms of the ban.

         700 MAFF at once sent letters to operators of all slaughterhouses, telling them of
         the proposed extension of the SBO ban and asking them to give effect to it on a
         voluntary basis, pending amendment of the Regulations.

         701 How the news of the experiment result and the action to be taken should be
         made public was the subject of discussion in the Cabinet. A draft press release
         prepared by the CMO was considered. It included a statement that the risk to human
         health was considered to be ‘minuscule’. In discussion it was suggested that this
         should be deleted, so that the statement would indicate that there was no risk at all.
         Mr Major, in summing up, said that Mrs Shephard should proceed with the
         announcement as planned.

         702 A lengthy press release was issued on 30 June, accurately describing the
         course of events, and setting out SEAC’s advice in full.

         703 This decision was a model of how government ought to handle such an issue.

            •   SEAC’s advice was sought as to the implications of the finding in the
                pathogenesis experiment.
            •   SEAC limited its advice to the effect this result had on the question of risk
                of transmission to humans and did not recommend the appropriate
                policy decision.
            •   MAFF and DH worked closely together in considering the
                appropriate response.
            •   The issue was discussed with Mrs Shephard at a meeting at which the CMO
                expressed his advice in favour of an extension to the SBO ban.
            •   The effect that such an extension would have on trade was considered.
            •   The Minister and the Parliamentary Secretary were in agreement that
                ‘protecting the public health was the first of MAFF’s aims’. The CMO’s
                advice would be followed, notwithstanding the potential for serious impact
                on trade.
            •   The practical implications were considered.
            •   The results of the experiment and the Government’s response were
                announced without delay.


138
                                                                                              PROTECTING HUMAN HEALTH


     •    There was swift consultation and prompt action. Slaughterhouses, local
          authorities and bodies consulted were individually informed of the extension
          of the Regulations.

Advances in knowledge of BSE

704 Between 1991 and 1995 a lot more was learned about BSE. Advances in
knowledge up to about September 1994 were summarised in a Report produced by
SEAC in September 1994 and published in February the following year.82
The following we find particularly significant:

     •    By September 1994, 57 cats had been confirmed as having contracted FSE,
          presumptively from feed containing the BSE agent.
     •    The following animals had contracted spongiform encephalopathies (SEs),
          in most cases presumptively from feed containing the BSE agent:

          – Nyala

          – Gemsbok

          – Arabian oryx

          – Greater kudu

          – Eland

          – Moufflon

          – Puma

          – Cheetah

          – Scimitar-horned oryx.

705 Strain-typing showed that, in contrast to scrapie, which had a number of
different strains, cases of BSE from different parts of the United Kingdom and in
different years were indistinguishable from each other but distinct from all
previously studied laboratory strains of scrapie.

706 In addition to the natural transmissions set out above, on 14 February 1992
BSE was found to have been successfully transmitted to a marmoset by cerebral
inoculation. This was the first transmission to a primate. A meeting of SEAC was
immediately called to consider the implications of this. SEAC concluded that as
marmosets had in the past been infected with SEs, including scrapie, using similar
methods, the results were not surprising and had no implications for the safeguards
already in place for human and animal health.

707 We have emphasised those last words, for they were significant.
SEAC’s ‘public advices’ on risk tended to focus on the question of whether the

82
     Transmissible Spongiform Encephalopathies: A Summary of Present Knowledge and Research                     139
FINDINGS AND CONCLUSIONS


         precautionary safeguards in place were adequate to protect the public. They did not
         comment on the effect that events had on the assessment of the risk that BSE might
         be transmissible to humans. Thus the impression was given that that risk never
         changed. There is no better illustration of this than the following passage of oral
         evidence given to us by Mr Gummer:

                   . . . during the period of time in which I was Minister and my junior Ministers
                   were with me, that science was tested all the time, but it did not change.
                   The advice was and continued to be that the risk to human beings was
                   remote . . .83

         708 To the casual reader of SEAC’s 1994 Report, nothing had changed. Thus,
         under the heading of risk assessment, SEAC wrote:

                   Our conclusion therefore is that, as the Southwood Working Party
                   determined, taking all the available evidence together, the risk to man from
                   BSE is remote.

         709 The careful reader, however, might have noted this passage which followed:

                   In conclusion, therefore, our scientific assessment is that the risk to man and
                   other species from BSE is remote because the control measures now in place
                   are adequate to eliminate or reduce any risk to a negligible level. We do
                   however point out that any species exposed already and before any bans
                   were effective could be incubating disease, and therefore continuous
                   monitoring is very important until any possible incubation period has
                   been exceeded.

         710 SEAC only evaluated the risk as still remote because precautionary measures,
         and in particular the human SBO ban, had been put in place. The Southwood
         Working Party, however, had not taken that view – at least in relation to human
         food, where they considered the risk remote even without an SBO ban.

         711 The advances in knowledge by September 1994 significantly altered the
         scientific evaluation of the risk that BSE might be transmissible to humans.
         Professor John Collinge84 told us:

                   Certainly the appearance in domestic and captive wild cats was a very
                   important development. It demonstrated that you could no longer really
                   plausibly argue that BSE was just scrapie in cows with all the same
                   properties. This agent, wherever it had originated from, had quite different
                   biological properties to scrapie as manifested by the extended host range of
                   affected species, including things like nyala and kudu as well as the cats that
                   had not been affected by scrapie before, so far as we were aware.

         712 Dr Tyrrell confirmed that the transmission of BSE to cats and wild cats had
         shifted his perception of the risk of transmissibility ‘a bit’. Dr Kimberlin said that
         his reaction to the cat was:



         83
              T94 pp. 75–6
140      84
              Professor of Molecular Neurogenetics at St Mary’s Hospital, London; a member of SEAC since December 1995
                                                                                                  PROTECTING HUMAN HEALTH


           Thank God we have got the SBO ban because if it should so happen that the
           species barrier between cattle and humans is no higher than between cattle
           and cats . . . then we would have a problem.

713 We do not criticise SEAC for what was a detailed and careful analysis of the
existing data. Nonetheless we think it a pity that its Report did not spell out more
clearly and simply the fact that perception of risk had changed since Southwood.
Had the Committee done so, its Report might have attracted some attention and
resulted in the public being better informed about risk. As it was, the Report appears
to have attracted no press coverage.

Knowledge about dose

714 One important experimental result did not receive comment in SEAC’s 1994
Report. The NPU had succeeded in transmitting BSE to sheep using an oral dose of
no more than ½ gram of BSE-infected brain. What is more, the sheep infected were
of a breed not susceptible to scrapie. The interim result of this experiment was
known in November 1990 and published in the Veterinary Record in October 1993.
The significance of this experiment seems to have been totally overlooked by
MAFF officials, and indeed by SEAC. We have not been able to discover why
this was.

715 The CVL had, in January 1992, initiated an ‘attack rate’ experiment under
which they had fed different quantities of BSE brain to cattle. The smallest quantity
was 1 gram and, in September 1994, MAFF officials learned that this had
transmitted the disease. There was general surprise and concern that such a small
quantity had proved infective. This result demonstrated the importance of avoiding:

     •     contamination of MBM designed for animal feed with SBO in the course of
           rendering; and
     •     contamination of cattle feed with pig and poultry feed containing that
           contaminated MBM in the feedmills.

716 Had the significance of the NPU experiment been drawn to the attention of
MAFF officials in November 1990, the extent of the danger of cross-contamination
might have been appreciated four years earlier.

Two dairy farmers die from CJD

717 In May 1990, in accordance with a recommendation of the Southwood
Working Party, the CJD Surveillance Unit (CJDSU) had been set up under
Dr Robert Will.85 Its main objective was to identify any change in the
epidemiological characteristics of CJD cases and to assess the extent to which they
were linked to the occurrence of BSE. The CJDSU summarised its progress and
findings in a series of annual reports, and Dr Will submitted articles about these to
The Lancet. Dr Will was a member of SEAC, and findings of the CJDSU were
reported to SEAC when they met.


85
     Consultant Neurologist at the Department of Clinical Neurosciences, Western General Hospital, Edinburgh.
     Volume 8 gives a fuller description of the establishment and work of the CJDSU                                 141
FINDINGS AND CONCLUSIONS


         718 There was a more immediate link with DH through Dr Ailsa Wight who, in
         September 1991, took over from Dr Pickles the responsibility for provision within
         DH of medical advice in relation to BSE and CJD and was DH’s observer on SEAC.
         Thus DH and, through DH, MAFF usually received confidential information about
         victims of CJD well before news of them became public. There was ample time to
         decide upon the appropriate official response to such news.

         719 On 6 March 1993 The Lancet published an article by Dr Will on the first
         recorded case of CJD in a dairy farmer. He had died the previous October. He had
         had BSE in his herd. The article concluded that the case was most likely to have
         been a chance finding and that ‘a causal link with BSE is at most conjectural’. The
         media naturally developed the conjecture that there might be a link between this
         case and BSE. Professor Lacey did not think that there was. Interviewed on the
         radio, he gave his opinion that the case had occurred too soon to have been
         contracted from BSE.

         720 The media interest led Mr Gummer to discuss a press release with Dr Calman,
         who agreed that it was necessary to reassure the public. On 11 March the CMO
         issued a public statement. This repeated the assurance about the safety of beef given
         by his predecessor, Sir Donald Acheson, in 1990 that we have criticised above.86

         721 We found it open to precisely the same criticism. Dr Calman was seeking to
         address fears that a farmer had somehow caught BSE from his cattle. Responding
         to such fears by emphasising that it was safe to eat beef naturally carried the
         inference that transmission of the disease from cow to human was impossible.
         That Dr Calman’s statement was in fact misinterpreted in this way is demonstrated
         by The Mirror’s report that:

                    Chief Medical Officer Dr Kenneth Calman had insisted that BSE could not
                    cause a related brain disease in humans.

         722 Dr Calman should have been careful not to make a statement in terms that
         suggested such a belief, for he considered that there was a real potential for BSE to
         move from cows to humans.

         723 On 23 March Mr Lowson commented in a minute for Mr Gummer’s attention:

                    It was not easy to get the CMO to make a statement in response to recent
                    press speculation about a possible link between BSE and human disease.

         724 The reason why MAFF wished the CMO to make a statement was, no doubt,
         because of the damage that public concern about BSE might cause to the beef
         industry. The evidence suggests that Dr Calman had reservations about complying
         with MAFF’s request for assistance. Having decided to comply with that request
         and make a public statement, he should have taken great care to ensure that his
         statement fairly reflected his appraisal of the risk posed by BSE.

         725 On 12 August 1993 The Daily Mail recorded the death from CJD, earlier in
         the month, of a second dairy farmer, who had had BSE in his herd. The CJDSU had
         been monitoring this case, and had concluded that there was nothing to suggest that
         it was other than a case of sporadic CJD. A DH spokesman was quoted by
142      86
              See para. 657 and following
                                                                                                  PROTECTING HUMAN HEALTH


The Daily Mail as saying that two cases might occur in dairy farmers by chance and
that it was not possible to reach any conclusions about a link between BSE and CJD.

Vicky Rimmer

726 Vicky Rimmer fell ill early in the summer of 1993 at the age of 15. She had a
neurodegenerative disease which the medical specialists were unable to identify. In
mid-September she went blind and fell into a coma. She remained in a coma until
she died on 21 November 1997, over four years later. The CJDSU now attributes
her death to CJD, but her illness did not have the characteristics of the cases now
classified as vCJD. In January 1994 the CJDSU was unsure whether her illness
was CJD.

727 It was in January 1994 that the press first started to write about Vicky Rimmer,
quoting her grandmother’s belief that Vicky had been infected as a result of eating
beef infected with ‘mad cow disease’. Dr Stephen Dealler and Professor Lacey were
reported to have concluded that this was the first case of BSE infecting a member
of the human race through food.

728 In response to intense media coverage, Dr Calman released a statement on
26 January. This stated that:

     •     no one knew what illness the patient was suffering from; and
     •     on the basis of the work done so far, there was no evidence whatever that
           BSE caused CJD and, similarly, not the slightest evidence that eating beef or
           hamburgers caused CJD.

729 We consider that it was reasonable for Dr Calman to make a public statement
to counter media reports which suggested that the link between Vicky Rimmer’s
disease and eating beefburgers was established. The terms in which he did so were
somewhat more emphatic than was desirable, but not to the extent that it would be
right to criticise him for his choice of language.

730 Dr Dealler’s and Professor Lacey’s conclusion that Vicky Rimmer had caught
BSE through food was speculative. In the next chapter we shall see the first of the
cases that have been identified by the CJDSU as cases of vCJD linked to BSE.



Chinks in the armour – April–December 1995

731 In this section we shall consider, from the viewpoint of public health, the
revelations that followed the takeover by the MHS of enforcement of Regulations
in slaughterhouses. We shall consider how government responded to what was
discovered. We shall look at growing concerns caused by further cases of CJD in
farmers and in young people and we shall look at official statements and media
comment in relation to the risk posed by BSE to humans. We shall cover the period
up to the end of the year.87

87
     Ministerial changes in MAFF and DH during this period included the following: Mr Douglas Hogg succeeded Mr William
     Waldegrave as Minister of Agriculture, Fisheries and Food on 5 July 1995. Mr Stephen Dorrell succeeded Mrs Bottomley as
     Secretary of State for Health in July 1995                                                                                143
FINDINGS AND CONCLUSIONS


         732 The MHS took over on 1 April 1995 with Mr Johnston McNeill as Chief
         Executive and Mr Philip Corrigan as Head of Operations. Mr Corrigan was
         succeeded in August 1995 by Mr Peter Soul. The MHS commissioned a survey of
         standards at slaughterhouses from Eville & Jones, a firm of private veterinarians
         which provided Official Veterinary Surgeon (OVS) inspection services.
         Deficiencies summarised in its report which existed at the time of takeover on
         1 April 1995, included widespread lack of awareness of SBO legislative
         requirements and instances of incomplete removal of spinal cord. The report noted
         significant improvements over the five months between April and August 1995.
         When Dr Cawthorne at MAFF learned of this report, he asked himself why these
         deficiencies had not been drawn to the attention of the SVS or the Meat Hygiene
         Division. We think that the explanation must have been poor OVS/local authority/
         VFS liaison.

         733 The MHS also organised an internal survey of slaughterhouse standards by its
         own Hygiene Advice Teams. These teams encountered occasional failures fully to
         remove tonsils, thymus and spinal cord, but felt able to report that SBO removal in
         the slaughterhall was carried out in accordance with the legislation.

         734 VFS staff were instructed to visit slaughterhouses once every two months and
         carry out a thorough inspection in company with MHS staff. They were instructed
         to examine, in particular, methods used to separate SBO from material intended for
         human consumption as well as staining and disposal of SBO. As we have seen,
         when looking at animal health, inadequacies in the handling of SBO led to the
         institution of a period of national surveillance.

         735 In May 1995 Mr Meldrum gave instructions that Meat Hygiene Inspectors
         (MHIs) should be told to take particular note of the operation of removing the spinal
         cord from the vertebrae. This led to an Information Note being circulated to all
         MHIs and OVSs instructing them to ensure the complete removal of spinal cord
         from the vertebral column. In July the question was raised as to whether a Meat
         Hygiene Inspector could refuse to apply the health stamp on the ground that not all
         spinal cord had been removed. MAFF lawyers replied in the affirmative. We think
         it significant that this should be in doubt over five years after the SBO Regulations
         were introduced.

         736 The July report on the results of the first round of national surveillance found
         widespread deficiencies in the handling of SBO, but made no mention of
         deficiencies in removing SBO from the carcass. In a submission to Mr Hogg,
         Mr Packer noted that the implications of the failures in the controls were for animal
         health, not for human health. Mr Meldrum confirmed that there was no public health
         problem because there was no question of SBO entering the human food chain.

         737 By the time of the second round of national surveillance, the importance of
         ensuring the complete removal of spinal cord had been specifically drawn to the
         attention of the VFS in accordance with Mr Meldrum’s instructions. On the second
         round of inspection, three instances were discovered of failure to remove SBO from
         the carcass. When this was reported to Mrs Browning, the Parliamentary Secretary,
         and to Mr Hogg, both were perturbed. Mr Richard Carden88 suggested that
         enforcement should be tightened up and prosecutions launched where companies
         repeatedly infringed the Regulations. Mr Hogg agreed that this should be done.
144      88
              The Grade 2 head of MAFF’s Food Safety Directorate
                                                                      PROTECTING HUMAN HEALTH


738 The surveillance results were reported to DH. Mr Meldrum assured Dr Metters
that specific and detailed instructions had since been issued by the MHS to their
staff on the checks necessary to ensure compliance with the legislation. Dr Calman
received copies of this correspondence and resolved to look carefully at the next
round of surveillance in order to see whether or not the deficiencies that had been
discovered were isolated incidents.

739 On 23 October Mr Meldrum wrote to Dr Calman informing him that SVS staff
had found a further four cases of health-stamped carcasses with portions of spinal
cord attached. He described these results as ‘disappointing’, but added:

          It is inevitable that instances of the type referred to will continue to be
          reported albeit at low frequencies since no system operated by humans can
          deliver at 100 per cent efficiency all the time.

740 Two days later Dr Calman met Mr Packer to ‘express disquiet about the
position on BSE’. Dr Calman said that he ‘could not be so unequivocal as he had
been in the past’ about the safety of beef. In a confidential file note he recorded:

          The issue remains, however, that the uncertainty has increased, rather than
          decreased. Urgent action is required to reassure the public that all steps are,
          and have been, taken to minimise any possible risk.89

741 When Mr Hogg learned of Dr Calman’s concerns, he called a council of war
of his junior Ministers and senior officials. We have already recorded, when looking
at animal health, Mr Packer’s advice that Mr Hogg should read the riot act to the
MHS and the slaughterhouse industry. In the formal instructions that Mr Hogg
proceeded to issue to Mr McNeill, he instructed him that his staff:

          . . . must ensure that all SBO is removed from a carcass before they give it a
          health stamp. Failure to do so should be viewed extremely seriously.

742 This led the MHS management to introduce what one union officer described
to us as a ‘disciplinary purge’. Immediate and emphatic instructions were issued to
the workforce that failure to ensure that all spinal cord was removed would be
treated as a serious disciplinary offence. Mr Hogg for his part met with
representatives of slaughterhouse operators and told them robustly that he would
only be satisfied with 100 per cent compliance with the rules and that those who did
not provide this would be prosecuted.

743 On 1 November Mr Don Curry, the chairman of the MLC, wrote a strong letter
to Mr Hogg expressing concern at breaches in the integrity of the SBO system, in
particular those leading to the four cases in which spinal cord had been found in
carcasses that had been passed as fit by meat inspectors for consumption. He wrote:

          We detect an attitude in the industry which says, ‘you have told us this
          disease was not a threat to humans so why do we need all these controls?’.
          The danger that such an attitude engenders to our market, both at home and
          overseas, is very worrying indeed.


89
     YB95/10.25/16.1–16.2                                                                   145
FINDINGS AND CONCLUSIONS


         744 This was one of a number of occasions in and after 1994 that the MLC
         commendably urged the importance of compliance with the SBO Regulations both
         on MAFF and on the industry. We would remark, however, that the attitude of
         which Mr Curry complained may well have been encouraged by some of the
         exaggerated reassurances that had been given earlier by the MLC.

         745 On 7 November Dr Calman and Dr Metters met Mr Hogg, Mrs Browning and
         Mr Packer. Dr Calman did not mince his words. He said he found the attitude of the
         farming industry and the slaughterhouses astonishing. While there was no evidence
         that meat was not safe, it could not be said with confidence that no contaminated
         offal had entered the food chain. If pressed on the safety of food containing MRM,
         he would be in a difficult position.

         746 On 20 November 1995 MRM was discussed at a meeting between Dr Calman,
         Mr Meldrum and other officials from both MAFF and DH. Dr Calman suggested
         that it was impossible to be 100 per cent certain that spinal cord was not being
         included in MRM derived from spinal column. Mr Meldrum confirmed that this
         was the position. It was agreed that SEAC should once again be invited to
         consider MRM.

         747 On this occasion it was DH that had played the lead role in pursuing an issue
         arising from BSE in respect of the safety of food. Dr (now Sir Kenneth) Calman is
         to be commended for the vigour of his reaction on learning that segments of spinal
         cord were escaping the attention of slaughterhouse operatives and meat inspectors.
         By pursuing this matter with Mr Hogg, and subsequently with Mr Meldrum and
         other MAFF officials, he was instrumental in ensuring that the question of MRM
         was brought back before SEAC.

         Action at last on MRM

         748 We saw that a paper on MRM was placed before SEAC in August 1994 and
         deferred. A revised paper was prepared for its meeting on 21 June 1995. This
         annexed MAFF’s paper on slaughterhouse practices that had been before SEAC in
         1990 and the EU Scientific Veterinary Committee’s recommendation that spinal
         column of cattle slaughtered in the UK should not be used for MRM.

         749 The paper informed SEAC that the transfer of responsibility of meat inspection
         to the MHS:

                . . . should ensure that no carcass is permitted to leave the slaughterhouse for
                human consumption unless the spinal cord has been completely removed.

         750 The paper recommended that:

                In the light of the changes which are to be made to the controls on SBO and
                the methods of enforcing these controls . . . SEAC is recommended to advise
                that the use of spinal columns from cattle born and slaughtered in the UK for
                the mechanical recovery of meat may continue.



146
                                                                      PROTECTING HUMAN HEALTH


751 SEAC duly concluded that:

          . . . provided in the slaughtering process the removal of spinal cord was done
          properly, the MRM process was safe and there was no reason for the
          Committee to change its advice.90

752 Just as in 1990, SEAC’s advice was premised on the total removal of
spinal cord.

753 When SEAC met on 28 November, it had a new chairman. Professor (later Sir)
John Pattison, who had been a member of the Committee since January 1995, had
replaced Dr Tyrrell. SEAC was informed that there had been 14 instances, involving
at least 25 carcasses, in which SBO had been left attached to carcasses after
dressing. The Committee was told of the steps that had been taken to tighten up
enforcement of the Regulations. After protracted debate, SEAC decided that until it
was clear that removal of spinal cord was being undertaken properly in all cases it
would be prudent, as a precaution, to suspend the use of vertebrae from cattle aged
over six months in the production of MRM.

754 SEAC’s advice was accepted by both Mr Hogg and Mr Dorrell. Despite
considerable resistance from the industry, the Order91 banning the use of bovine
vertebral column for the recovery of meat by mechanical means was made on
14 December 1995 and came into force the following day. For practical reasons, no
exception was made in respect of calves aged less than six months.

755 The minutes of SEAC’s meeting suggest that the decision was a close-run
thing, with arguments from Dr Will and Professor Pattison winning the day. Would
the decision have been the same, if the Committee had not known about the result
of the attack rate experiment and had been unaware of concerns raised by incidents
of CJD in farmers and young people? Would SEAC in 1990 have taken the same
decision, if aware then of the extent of the failures to remove spinal cord identified
in 1995? We do not believe that a confident answer can be given to either question.

756 As to preventing fragments of spinal cord getting into human food, SEAC’s
decision was to a large extent a case of shutting the stable door. Measures were in
hand to ensure effective implementation of the duty to remove all spinal cord from
the carcass. The more significant benefit of the new Order was that it kept dorsal
root ganglia out of human food. The benefit was not appreciated at the time. The
pathogenesis experiment had not yet shown these to be infective – the positive result
was to come later.

757 Has MRM infected humans with BSE in the years up to 1995, and if so on what
scale? It is too early to attempt to answer this question. What is, we think, now clear
is that this was the route by which infectious material was most likely to end up in
human food during that period.

Cause for concern

758 In the second half of 1995, the public learned of the death from CJD of a third,
and then a fourth, dairy farmer. The third had died in December 1994. There had
90
     YB95/6.21/2.6
91
     The Specified Bovine Offal (Amendment) Order 1995                                     147
FINDINGS AND CONCLUSIONS


         been two cases of BSE on the farm where he worked. SEAC held a special meeting
         to consider this case on 13 January 1995. They concluded that the occurrence of
         three cases of CJD in dairy farmers with BSE in their herds was worrying, but that
         more information was needed before any conclusions could be drawn. The death of
         this farmer was reported in the national press on 29 September. On that day the
         CMO learned of a suspected fourth case.

         759 Again SEAC met in special session. The fourth farmer was still alive, but
         suspected of having CJD. His herd had had a single case of BSE in 1991.

         760 At this special meeting, SEAC considered that although four cases were likely
         to be more than might be expected as a chance phenomenon for the known
         population frequency of the disease, analysis of CJD in Europe showed that the
         incidence of the disease in farmers was similar in countries with no or very few
         cases of BSE. An important factor was that the clinical and pathological features
         of these cases were no different from those found in classical sporadic CJD.
         SEAC released a statement of its conclusions.

         761 These findings remain unexplained. Among occupational groups exposed to
         BSE, farmers remain the exception in having such an excess over the incidence of
         CJD for the population as a whole. Recent transmission studies in mice indicate that
         the causal agent in these cases has various characteristics, including incubation
         period and neuropathology, which are distinct from both vCJD and BSE.

         762 Thus they appear to have been typical cases of sporadic CJD, although it is not
         easy to accept that these four cases were simply a statistical anomaly.

         763 The farmers were not the only cases of CJD that were causing anxiety. Two
         more adolescents had been diagnosed as having contracted the disease. SEAC
         released a statement saying that it was not possible to draw any conclusions from
         these cases, which needed to be studied in great detail. SEAC added that cases of
         CJD had been found in the same age-group in other countries. This was true, but
         such cases were extremely rare. Sporadic CJD almost always attacks the elderly.

         764 Further reports of suspected cases of CJD in young people were received by
         the CJDSU. By the year-end, ten cases of patients aged under 50 had been referred
         to them. Three of those had been confirmed by neuropathology.

         765 The scientists of the CJDSU were not alone in becoming concerned about
         cases of CJD in young people. Professor Collinge, who was conducting BSE
         experiments with transgenic mice, recognised these cases as extraordinary and
         feared that they could represent the transmission of BSE to humans. At a meeting
         with Dr Calman at the end of October he told him of his fears. In December 1995
         Professor Collinge accepted an invitation to become a member of SEAC.

         Public debate

         766 Other scientists expressed their concerns more publicly. Dr Stephen Dealler
         and Dr Will Patterson had been carrying out calculations of the number of cattle
         subclinically infected with BSE that must have been slaughtered and eaten. Their
         conclusion that these totalled 1.5 million received wide publicity in the press.
148
                                                                      PROTECTING HUMAN HEALTH


‘Most beef eaten already exposed to mad cow agent’ was the headline in the
Daily Telegraph.

767 On 1 December Sir Bernard Tomlinson, Emeritus Professor of Pathology at
Newcastle University, said in a radio interview that he would not eat a beefburger
and that all offal should be kept from public consumption. His views received wide
press coverage. In The Times, he was quoted as saying:

          I have become more cautious because of recent CJD cases in dairy farmers
          and teenagers. These seem to be more than coincidences. My feeling is that
          it is possible that BSE is transmitting to humans.

768 In a television interview on 3 December, Mr Dorrell explained that the
Government had removed from the food chain all organs which could possibly carry
the risk of transmission of BSE – even if it were transmissible. ‘So there is, you are
saying, no conceivable risk from what is now in the food chain; that’s the position?’
asked the interviewer, Jonathan Dimbleby. ‘That is the position’, confirmed
Mr Dorrell. Mr Dorrell told us that he regretted that answer because it went further
than the words of his Chief Medical Officer. We think that it was regrettable that he
gave a public assurance in terms more extreme than he could justify. He told us that
it led to his being quoted in the press the next day as saying that there was no
conceivable risk from eating beef.

769 The words of the CMO, to which Mr Dorrell referred, had been included in a
press release in October to mark the release of the CJDSU’s fourth annual report.
Dr Calman stated:

          I continue to be satisfied that there is currently no scientific evidence of a
          link between meat eating and development of CJD and that beef and other
          meats are safe to eat. However, in view of the long incubation period of CJD,
          it is important that the Unit continues its careful surveillance of CJD for
          some years to come.92

770 We do not think that Dr Calman should have gone out of his way on this
occasion to volunteer the unqualified statement that he was satisfied that beef and
other meats were safe to eat. We believe that at this time Dr Calman had concerns
about slaughterhouse practices, which he expressed to Mr Packer later in the month.
He also had concerns about the dairy farmers that had contracted BSE. If he was
going to make a statement about the safety of beef, he should have made it plain that
this depended on an improved standard of compliance with the SBO Regulations by
those who worked in slaughterhouses.

771 Neither Dr Calman’s assurance about beef in October, nor Mr Dorrell’s
assertion that there was no conceivable BSE risk from food, did much to quell the
alarm raised by Sir Bernard Tomlinson. The Local Authorities Catering Association
received hundreds of calls from worried parents and head teachers about school
meals, and advised school cooks to substitute turkey, chicken and pork for beef.
On 8 December The Independent reported that 1,150 schools had taken beef off the
menu or were offering alternatives.


92
     YB95/10.05/3.2                                                                        149
FINDINGS AND CONCLUSIONS


         772 On learning that schools and caterers were beginning to remove beef from the
         menu, Dr Robert Kendell, the Chief Medical Officer for Scotland, decided to make
         a public statement. He did this on 7 December in these terms:

                    The Government’s independent scientific advisers are saying consistently
                    that there is no evidence at all that eating beef or other foods derived from
                    beef is dangerous. My general advice to people is therefore to carry on eating
                    what you want to eat as you were before.

                    We have no evidence of any connection between BSE and CJD. However,
                    both conditions are being monitored and studied by scientists, in this country
                    and abroad, as there is much about both that is still unknown.93

         773 We have the same concerns about this statement that we had about
         Dr Calman’s. Dr Kendell told us that, from early 1995 onwards, he was becoming
         increasingly concerned that BSE might have implications for human health. He told
         us that some of his concerns were allayed by Mr Hogg’s firm stance on the SBO
         Regulations and the ban on the use of bovine vertebral column for the recovery of
         MRM. We think that Dr Kendell should have made it plain in his statement that the
         safety of eating beef was dependent on strict compliance with the precautionary
         measures introduced by the Government.

         774 BSE was discussed in the Cabinet on 7 December. Mr Hogg explained about
         the problems discovered in slaughterhouses and the action that he had decided to
         take in relation to MRM. In summing up the discussion which followed, the Prime
         Minister said:

                    . . . that there was a disturbing degree of public anxiety over BSE once more
                    and that the Government must be ready with an immediate and coherent
                    response. The key element in that response should continue to be the
                    assurance from the Government’s chief professional advisers that there was
                    no evidence that the disease could be transmitted to humans.94

         A campaign of reassurance

         775 MAFF Ministers and officials met the same afternoon to discuss the way
         ahead. They decided to use SEAC to try to get the message across that beef was safe.
         Professor Pattison would be invited to draft a letter to the press. Mr Hogg instructed
         Mr Eddy to draft a questionnaire for SEAC with the intention that the answers that
         they gave should be made public.

         776 On 8 December The Independent published a lengthy article by Dr Will.
         The tone of this was generally reassuring, although it contained a caveat that the
         possibility of a link between BSE and CJD could not be excluded for many years
         because of the long incubation period. It ended:

                    I do not believe it is reasonable to conclude that there is significant risk
                    from eating beef. I have therefore not altered my consumption of beef or
                    beef products, and neither have any of my colleagues at the
                    CJD Surveillance Unit.
         93
              See also vol. 9: Wales, Scotland and Northern Ireland
150      94
              YB95/12.07/14.5
                                                                   PROTECTING HUMAN HEALTH


777 On the same day Professor Pattison and Dr Will, acting on behalf of SEAC,
sent a long letter about the safety of beef to The Times. The Times was only prepared
to publish this in an edited form, an offer which was declined. The letter was
adapted and turned into a letter to Mr Dorrell and Mr Hogg, and presented to the
press at a press conference on 14 December, attended by Mr Hogg, Mrs Browning,
Dr Calman, Professor Pattison, and Mr McNeill (of the MHS). The letter, after
describing the precautionary measures that the Government had taken, and the
strengthening of those measures, stated that:

       On the basis of the measures taken SEAC has a high degree of confidence
       that the beef reaching the shops is safe to eat.

778 This was a message that those who gave the press conference did their best
to reinforce.

779 It is apparent to us that members of SEAC were pressed by government to
intervene in the public debate about the safety of beef. We believe that this is
something that was likely also to be apparent to members of the public. SEAC’s
proper role was to provide expert advice to the Government – advice which it was
normally desirable to make public. If it appeared to the public that members of
SEAC were being used to provide publicity to bolster the beef market, SEAC’s
credibility was likely to be damaged. We consider there was a danger of that on this
occasion. When we look back on events in December 1995, we think that it would
have been preferable if SEAC had not become involved in the public debate in
this manner.

780 But for the intervention of Mr (now Sir Richard) Packer, Professor Pattison
would have become even more embroiled in the ‘beef is safe’ campaign. After the
press conference on 14 December, the MLC filmed an interview with Professor
Pattison with the intention of using this as part of its advertisements for beef that
were to be televised. When Mr Packer learned of this, he was concerned that it might
‘be interpreted as associating Professor Pattison unduly with the beef lobby, or in
other words, could be used to justify claims that he lacked independence’.
Mr Packer intervened and Mr Colin Maclean of the MLC reluctantly agreed that
the recorded interview with Professor Pattison should not be used for
advertising purposes.

781 We consider that Mr Packer’s concerns were well founded. We commend
him for his prompt intervention. This was an incident in a vigorous advertising
campaign which the MLC ran in 1995. In the course of that campaign there were
occasions when hyperbole displaced accuracy. Our criticisms of these can be found
in Chapter 6 of vol. 6: Human Health, 1989–1996. Although he was not always
personally involved in the choice of wording in the MLC’s promotional material,
Mr Maclean has accepted that as Director-General he was responsible for it.



The final months

782 We come to the last section of this part of our narrative – the final months
leading up to the Government’s announcement that young victims of a new variant
of CJD had probably caught BSE. In the final days leading up to 20 March 1996,          151
FINDINGS AND CONCLUSIONS


         there was frantic activity. In January and February the contemporary documents
         give no hint that anyone in MAFF or DH appreciated the storm that was gathering.
         Do they paint an accurate picture? Were MAFF and DH taken by surprise when
         scientists at the CJDSU identified a new variant of CJD and SEAC concluded that
         it was probably linked to BSE? Had they given any thought to how they might
         respond in that eventuality? Should they have done? Was the action taken in the
         final days an adequate response to the situation? If there was any delay in waking
         up to the fact that a crisis might be approaching, did it affect the outcome?
         These are some of the questions that we shall be considering in this section.

         783 Before turning to these important matters, we propose to follow a sub-plot of
         less significance. In the last section, we looked at action being taken by the
         Government and by the MLC in an attempt to allay concerns about whether it was
         safe to eat beef. Further steps to achieve this object continued to be taken in 1996.
         We consider these both with a view to examining whether they were appropriate in
         the circumstances and for the light they throw on the extent to which those involved
         appreciated the storm that was about to break.

         Mr Hogg’s questions

         784 In the previous section (paragraph 775) we saw that Mr Hogg decided that
         SEAC should be asked a number of questions. This was not because he wished to
         know the answers. It was in the hope that the answers would be suitable to publish
         in order to give reassurance to those who were worried about the safety of
         eating beef.

         785 This was a venture of which the MLC approved. It also hoped to make use
         of SEAC’s answers in its campaign to restore consumer confidence in beef.
         Dr Kimberlin, who was a member of SEAC, was also retained as a paid consultant
         to the MLC. Mr Colin Maclean sent Dr Kimberlin a list of model answers to
         SEAC’s questions. He explained:

                We agree that we need succinct answers to these questions and my
                colleagues in our PR company . . . have drafted the sort of answers they
                would like to see (although they cannot put words into SEAC’s mouth!).
                However, this should give you some feel for what we would initially like
                before you face the questions in SEAC. Anything you can do to help get
                crisp answers would be a big help.

         786 The model answers, as one might expect, all provided the maximum
         reassurance as to the safety of beef.

         787 We do not think that Mr Maclean should have asked Dr Kimberlin to provide
         this assistance. It put him in a position where his interest in helping the MLC might
         reasonably have been perceived to conflict with his duties as a member of SEAC.
         Dr Kimberlin did not perceive that the request created a potential conflict of interest.
         He told us that when addressing the questions as a member of SEAC he was wearing
         his SEAC hat, not his MLC hat. He did not inform SEAC of the MLC’s request
         when discussing the answers to the questions.

152
                                                                       PROTECTING HUMAN HEALTH


788 SEAC considered the questions when they met on 5 January 1996 and again
on 1 February. The Committee members did not agree on all the answers and the
exercise was never completed; it was overtaken by events in March. Dr Kimberlin
suggested answers of the kind that the MLC wanted. One was virtually verbatim in
the form of the suggested model answers. All were reassuring about the safety of
beef. We do not suggest that these represented other than Dr Kimberlin’s own
opinions. Thus there was in fact no conflict between his duty to advise objectively
as a member of SEAC and the interests of his client, the MLC. There was,
nonetheless, the appearance of a conflict. Dr Kimberlin should have told the
members of SEAC of the request that the MLC had made, so that no one would have
been able to suggest at the time or subsequently that he had a hidden agenda.

789 Suggested answers to the questions from other members of SEAC were not
succinct or unequivocal. They would have been quite unsuitable for use in support
of a ‘beef is safe’ publicity campaign. We think that these members were not
prepared to lend themselves to the exercise that Mr Hogg had planned. With
hindsight we can see that it was not a desirable exercise. In the first place, it diverted
SEAC from more important work which they might otherwise have been asked to
do. In the second place, we consider that the appropriate role for SEAC was to
provide advice to the Government, not to provide publicity material to bolster the
beef market. In the third place, if SEAC had provided the sound bites which had
been wanted, the public would have perceived them for what they were – publicity
material – and SEAC’s credibility would have been damaged.

790 Mr Hogg and his officials gave further consideration to how to support the beef
market at a meeting in the middle of January. Mr Hogg concluded that MAFF’s
principal role was to put factual information into the public domain and that MAFF
should not be involved with the MLC campaign. We think that this was a wise
decision. MAFF set about preparing their own information pack and revising two
booklets about BSE.

791 By the end of February MAFF had prepared a leaflet entitled ‘British Beef and
BSE: The Facts’, which was intended for a wide distribution. On the front page
it stated:

         Two facts should be made absolutely clear at the outset:

         Fact 1 There is currently no scientific evidence to indicate a link between
         BSE and CJD.

         Fact 2 The independent expert committee set up to advise the
         Government on all aspects of BSE is satisfied that British beef is safe to
         eat.

792 Dr Wight, who was leading for DH on the medical aspects of BSE and CJD
and attended SEAC’s meetings as an observer, met with MAFF officials on
28 February. The next day she minuted Dr Metters, suggesting that there was ‘some
merit in the leaflet being issued jointly by both Departments’. Dr Metters did not
agree. He replied:

       . . . some statements are too definite and in time may be seen to be wrong.
       We should not follow MAFF’s hyperbole of reassurance. We must leave DH                153
FINDINGS AND CONCLUSIONS


                    Ministers and CMO in particular, an escape route if any of these categorical
                    statements turns out to be WRONG.

         793 Mr Richard Carden, Head of the Food Safety Directorate, told us that MAFF’s
         publicity material went to Ministers ‘on the precise day when the first report
         suggesting there was a new variant of CJD came through’ and that it was overtaken
         by events.

         794 The fact that at the end of February Dr Wight was in favour of DH
         collaborating with MAFF in putting out this reassuring material suggests that she
         had no inkling of the storm that was about to break. The same can be said of the
         MAFF officials who placed the material before their Ministers at the moment that
         the thunder began to rumble.

         SEAC’s meetings on 5 January and 1 February 1996

         795 SEAC met on 5 January 1996.95 Dr Will updated members on the current state
         of CJD surveillance. He drew attention to the number of cases of CJD diagnosed in
         young people. Between 1970 and 1989 no one under 30 had contracted CJD in the
         UK.96 Since 1990 there had been four definite cases and one possible. Two of the
         cases had unusual pathology and Dr Will thought that there was a very high chance
         that they were genetic.

         796 The minutes of the meeting, as finally agreed, recorded that:

                    Dr Will was not unduly concerned at the overall number of CJD suspect
                    cases that had occurred in the under 30 age bracket. What he did find
                    worrying was that all the cases had occurred over a very short period.
                    Professor Collinge was extremely worried at the occurrence of this number
                    of young cases in such a short period, which could suggest a link to BSE.
                    He requested that a formal statistical analysis be carried out to assess this
                    further. The Committee concluded that the situation demanded the
                    continuation of intensive monitoring of CJD.97

         797 Following the meeting, Mr Eddy, SEAC secretariat, sent a full note of the
         entire proceedings to Mr Meldrum, who had asked for this. Mr Meldrum told us
         that he was already concerned about the cases of CJD in young people and that
         Mr Eddy’s minute indicated that there was no additional reason for concern.

         798 Dr Wight told us that it was her practice to circulate a minute of SEAC
         meetings only if they had raised something that was relevant to public health, or
         required action that the Department needed to take forward, which senior officers
         needed to be aware of. On this occasion she sent a minute to Dr (now Sir) Kenneth
         Calman, which recorded the cases of CJD in young persons and added:

                    Although this is a significant increase over the incidence in the UK in this
                    age group during the preceding surveillance period, it is not without
                    precedent worldwide.
         95
              SEAC’s membership had been strengthened by the addition of Professor John Collinge, Dr Michael Painter,
              Professor Peter Smith and Professor Jeffrey Almond
         96
              Save for some young people infected as a result of being injected with contaminated growth hormone
154      97
              YB96/1.05/1.8 para. 25
                                                                     PROTECTING HUMAN HEALTH


799 This was an inadequate report of this important item of SEAC’s business.
Dr Wight’s minute neither suggested that the figures were cause for concern nor
disclosed that the head of the CJDSU considered them cause for concern. The
cluster of young cases observed within such a short period were without precedent
in the world, let alone in a single country, and there had been no such sporadic cases
in the UK in the previous surveillance period. Dr Wight’s statement that ‘it is not
without precedent worldwide’ was misleading and encouraged false reassurance.
When giving evidence, she commented that her statement had been ‘not quite
correct’. She had meant to say that cases in young persons were not without
precedent worldwide. She added, ‘I probably dashed this off too quickly.’

800 Insofar as Dr Wight made no mention of the concerns expressed by Dr Will
and Professor Collinge, we do not believe that she appreciated the significance of
what was said. We consider that she should have communicated Dr Will’s concerns
to the CMO. In the event, her minute went on to deal with recommendations in
relation to research, and she appears to have thought that this was the most
important item that arose at the meeting, so far as DH was concerned. Dr Wight’s
minute was copied to Dr Metters and Dr Eileen Rubery, her immediate superior,
among others. It did not alert anyone to the fact that the young victims of CJD were
cause for concern. We are not surprised.

801 SEAC met again on 1 February. Dr Will’s concerns about the young cases of
CJD had increased because they appeared to share both a novel pattern of clinical
symptoms and a novel pathology, although it was still too soon to reach a concluded
judgement about these. Dr Will informed SEAC of these developments.
The minutes record that he:

          reiterated that the crucial issue is not simply the young age or pathology of
          recent cases but the short time scale in which 5 cases in individuals under
          30 years of age had occurred.

802 Dr Will told the Committee that his colleague, Dr James Ironside’s,98 view was
that it was premature to decide that these cases were linked with BSE.

803 Professor Smith confirmed Professor Collinge’s suggestion that these cases
were very significant in statistical terms. Professor Pattison’s concern about the
cases in young people was minuted. Professor Collinge told us that he reiterated his
concerns that this was likely to represent BSE transmission to humans. Dr Will told
SEAC that he intended to publish two scientific papers, one being about the young
cases of CJD.

804 Mr Eddy circulated a minute about the meeting to Mr Hogg, Mrs Browning,
Mr Packer, Mr Carden and Mr Meldrum. We think that he should have included a
clear warning of the concerns that had been expressed about the young cases and the
possibility that they might prove to be linked to BSE. He did not do so. He referred
to the papers to be published by Dr Will as likely to give rise to problems which
were essentially presentational.

805 Dr Wight minuted Sir Kenneth Calman about the meeting, with copies to
Dr Metters and Dr Rubery, among others. Once again her minute was inadequate in
that it failed adequately to express the concerns of members of SEAC about the
98
     Neuropathologist at the CJDSU                                                        155
FINDINGS AND CONCLUSIONS


         young cases. In describing the conclusions that might be drawn from these, she used
         language which suggested that there was, in reality, no likelihood of a link between
         BSE and a new variant of CJD. We are inclined to think that this was, in fact,
         Dr Wight’s own understanding. That would explain her support for issuing
         reassuring publicity, which persisted until the end of the month. Although a careful
         reading of her minute of the February meeting should have alerted the reader to the
         fact that young victims were a cause for concern, Dr Wight should have put this
         beyond doubt by referring to the concerns expressed by Professor Pattison and
         Professor Collinge.

         806 We observed at the start of this section that the contemporary documents gave
         no indication that either MAFF or DH was aware in February of the storm that was
         gathering. The evidence given to us by some of the witnesses painted a different
         picture. We propose to defer our analysis of this evidence until we have taken on
         the story that is supported by contemporary documents to its close.

         The storm clouds gather

         807 On 1 March Mr Eddy passed on to Mr Meldrum some disconcerting news that
         he had just received from Dr Wight. It was looking ‘rather firmer’ that the cases of
         CJD in young people represented the emergence of a new sub-population of the
         disease. Dr Wight had suggested a meeting between MAFF and DH officials and
         press officers to discuss how it should be handled. He had agreed with Dr Wight
         that it would be absolutely essential in handling the news to have some form of
         statement from SEAC as to the implications. He would keep Mr Meldrum posted
         on developments.

         Rumbles of thunder

         808 SEAC met on Friday 8 March. Dr Ironside gave a presentation showing that a
         subset of young people with CJD had been identified with a tendency to a long
         duration of illness and a unique neuropathology. The pathology differed from the
         rare young cases of CJD that had occurred abroad.

         809 Later that day, Mr Mike Skinner99 minuted Sir Kenneth Calman and Mr John
         Horam.100 He informed them that SEAC had concluded that exposure to BSE in the
         1980s was a likely explanation for the novel cases of CJD.

         810 Sir Kenneth Calman received Mr Skinner’s minute on Monday 11 March.
         After discussing the position with his colleagues he decided to call a meeting with
         MAFF. This took place on 13 March.

         811 On 11 March some members of SEAC made a visit to a slaughterhouse. They
         saw SBO being properly removed, identified and treated, and decided that there was
         no need to recommend any additional precautionary measures at that stage.

         812 On 12 March Mr Eddy minuted Mr Packer to tell him of SEAC’s conclusions
         about the novel cases of CJD. Mr Packer told us that from that date the pace of
         99
               Mr Skinner had succeeded Mr Charles Lister as DH secretary to SEAC in January
         100
               Mr Horam became a Parliamentary Under-Secretary for Health on 29 November 1995 and was given responsibility for
156            BSE and CJD from 31 January 1996
                                                                    PROTECTING HUMAN HEALTH


events became frenetic as it became more apparent every day that they would
shortly be at the centre of a major national crisis.

813 Mr Hogg told us that he learned of the approaching crisis when Mr Packer
came to his room one evening and told him that SEAC was coming to the view that
BSE was transmissible to humans. There was no record of this visit, but Mr Hogg
believed that it must have been sometime after SEAC’s meeting on 8 March.

814 On 13 March Sir Kenneth Calman and other DH officials met Mr Packer,
Mr Meldrum and MAFF officials. Professor Pattison was also present. Mr Packer
advised Professor Pattison that SEAC should consider what action it thought
appropriate. If the Committee made a recommendation, the Government would be
likely to follow it. He added that it did not follow from the worst case scenario that
the current rules needed to be changed. In a minute to Mr Hogg the same day,
Mr Packer said that some elements in SEAC were apparently thinking of
recommending a ban on the consumption of beef from animals over two years old.
He questioned whether the cost of such a measure would be proportionate to any
reduction in risk. He added:

       Nevertheless, on the pessimistic scenario worries about the economic
       consequences of SEAC recommendations would be academic. If SEAC and
       the CMO issue statements acknowledging the possibility of BSE/CJD
       transmission I am sure that the public and market reaction would be such that
       the political and economic effects would be a disaster of unparalleled
       magnitude so far as UK food scares are concerned. The consumption of beef
       would be likely to fall immediately to a small proportion of its former level.

815 In discussion on that day and the next, Mr Packer and Mr Hogg agreed that it
was necessary to get clear advice from SEAC as to the facts and the steps which the
Government should take. They also agreed that they should ‘avoid seeking to
influence in any way’ the conclusions to which SEAC would come. On 14 March
Mr Hogg wrote to Professor Pattison asking him to submit SEAC’s advice as soon
as he was in a position confidently to do so.

The storm breaks

816 SEAC held an emergency meeting on Saturday 16 March. Dr Will gave details
of nine confirmed and three suspect cases of CJD in young patients. Three
independent neuropathologists had confirmed that these cases formed ‘a distinct
entity unlike any previously seen CJD’. There was intense discussion of what, if
any, additional precautionary measures should be put in place. So far as human
health was concerned, options discussed included:

   •   a ban on cattle aged more than 30 months entering the human food chain; and
   •   a requirement that meat from animals over 30 months old should be
       completely deboned and their obvious nervous and lymphatic
       tissue removed.

817 The discussion was inconclusive, apart from agreement that SEAC should
‘recommend that all steps should be taken to ensure that the current SBO ban be
enforced completely rigorously’. Finally SEAC agreed on a statement to Ministers.        157
FINDINGS AND CONCLUSIONS


         This noted that it had proved impossible adequately to explain the cases of CJD in
         young people, and continued:

                This is cause for great concern. On current data the most likely explanation
                at present is that these cases are linked to exposure to BSE before the
                introduction of the SBO ban in 1989.

         818 Mr Carden told the Inquiry that SEAC’s desire to give further thought to the
         need for new measures caused acute difficulty over the following three days.
         At meetings during this period, Mr Hogg, Mr Packer and officials explored with
         Professor Pattison what SEAC’s likely recommendations might be, but it
         became clear that SEAC could not reach a final view until it had fully assessed all
         the options.

         819 On Monday 18 March Mr Hogg discussed with his officials a plan of action
         that he had decided on. He suggested that there should be a ban on the sale of beef
         from animals over 30 months old (what became known as ‘the Over Thirty Month
         scheme’), and a judicial inquiry into the Government’s handling of BSE. Both
         Mr Packer and Mr Meldrum questioned whether the 30 months scheme was
         proportionate and cautioned against taking action ahead of advice from SEAC.
         Mr Hogg said that he was not prepared to rely on the SBO ban as the sole line of
         defence when the controls were not being implemented perfectly. He wanted ‘belt
         and braces’. Furthermore he was minded to recall all beef products from the food
         chain. In the early afternoon Mr Hogg had a meeting with Professor Pattison, who
         said that SEAC would not be in a position to advise until after its next meeting,
         which was scheduled for 23/24 March. He expressed a personal view that
         Mr Hogg’s proposal of a 30 months scheme was ‘justifiable, logical and not
         irrational’.

         820 Before his meeting with Professor Pattison, Mr Hogg had signed a letter to the
         Prime Minister, to be sent jointly by himself and Mr Dorrell. This explained what
         had occurred to date and said that a detailed analysis of what would need to be done
         would depend in part on SEAC’s recommendations and the policy conclusions that
         would flow from them. Before Mr Major had seen this, Mr Hogg told Mr Michael
         Heseltine, the Deputy Prime Minister, about the information it contained.
         Mr Heseltine was plainly horrified. He asked about the implications of slaughtering
         the entire national herd, and interrupted a meeting that Mr Major was holding to
         draw his attention to the joint letter.

         821 Later in the day Mr Hogg sent a second letter to the Prime Minister. This set
         out his proposal for the 30 month scheme. It raised the possibility of withdrawing
         all beef products from the food chain and proposed a judicial inquiry into the
         Government’s reaction to BSE.

         822 In the early evening Mr Hogg and Mr Dorrell met, accompanied by their
         officials. Mr Hogg told Mr Dorrell of his proposal for a ban on beef from animals
         over 30 months old and for a judicial inquiry. The implications for DH of SEAC’s
         findings were discussed. These included investigations into the safety of products
         other than food which had bovine content, such as vaccines.


158
                                                                   PROTECTING HUMAN HEALTH


823 Late in the evening Mr Hogg, Mr Dorrell and other members of the Cabinet
met the Prime Minister. It was decided to call a ministerial meeting the following
day and invite the CMO, the CVO and Professor Pattison to give their advice.

824 At the ministerial meeting on the morning of Tuesday 19 March, Mr Hogg told
us that his recommendations were comprehensively rejected by his colleagues and
that he accepted the decision of the meeting, although he believed it to be mistaken.
This rejection is not clearly apparent from the contemporary record of the meeting.
What is clear is that Professor Pattison would not be drawn into giving specific
advice in advance of SEAC’s meeting, scheduled for the weekend. After lengthy
discussion it was decided that further information from SEAC was necessary in
order to enable the Government to make a statement that included something of
substance. ‘An early meeting of SEAC would therefore be encouraged.’

825 Encouragement resulted, by 4.00 in the afternoon, in the assembling of
Professors Pattison, Almond, Smith and Collinge and Dr Will in London, and the
establishment of telephone linkage with Mr Bradley and Dr Kimberlin in Paris,
where they had been attending a meeting of the Office International des Epizooties.
Different options were discussed at length. By late in the evening no conclusion had
been reached, but the meeting had received a message that the Government needed
advice by 1030 the next morning. The meeting adjourned until 0800 the next day.

826 On 20 March it became clear that the news about BSE had leaked. ‘Official:
Mad cow can kill you’, announced the headline of The Mirror. Other newspapers
also carried the story that the Government was to announce the possibility that BSE
could be transmitted to humans.

827 SEAC reconvened at 0800. By 0930 the Committee had agreed a statement.
After saying that 10 cases of CJD in young people had been identified,
this continued:

       On current data and in the absence of any credible alternative the most likely
       explanation at present is that these cases are linked to exposure to BSE
       before the introduction of the SBO ban in 1989.

       CJD remains a rare disease and it is too early to predict how many further
       cases, if any, there will be of this new form.

The Committee went on to make the following recommendations:

       a. that carcasses from cattle aged over 30 months must be deboned in
       licensed plants supervised by the Meat Hygiene Service and the trimmings
       must be classified as SBO.

       b. prohibition on the use of mammalian meat and bonemeal in feed for Rall
       farm animals.

       c. that HSE and ACDP, in consultation with SEAC, should urgently review
       their advice in the light of these findings.

       d. that the Committee urgently consider what further research is necessary.
                                                                                        159
FINDINGS AND CONCLUSIONS


                The Committee does not consider that these findings lead it to revise its
                advice on the safety of milk.

                If the recommendations set out above are carried out the Committee
                concluded that the risk from eating beef is now likely to be extremely small.

         828 The Cabinet met at 1045 to consider SEAC’s statement and a statement that
         Sir Kenneth Calman had prepared. It was decided that SEAC’s recommendations
         would be accepted in full. It was also agreed that both Mr Dorrell and Mr Hogg
         should make statements to the House of Commons.

         829 That afternoon Mr Dorrell made the first statement to the House. He described
         the CJD Surveillance Unit’s findings of a new variant of CJD in young people and
         SEAC’s conclusion that the most likely explanation was that those cases were
         linked to exposure to BSE before the introduction of the SBO ban in 1989. He
         explained the recommendations that SEAC had made and said that the Government
         had accepted them in full and would implement them as soon as possible. He then
         turned to a question that Sir Kenneth Calman had raised that morning – the question
         of whether children were more at risk than adults of contracting CJD. He stated:

                There is at present no evidence for age sensitivity and the scientific evidence
                for the risks of developing CJD in those who eat meat in childhood has not
                changed as a result of the new findings. However, parents will be concerned
                about the implications for their children, and I have asked the advisory
                committee to provide specific advice on that issue following its
                next meeting.

         830 Mr Hogg followed with his statement. He confirmed that the Government had
         accepted SEAC’s recommendation that carcasses from cattle over 30 months must
         be ‘deboned in specially licensed plants supervised by the MHS, and that any
         trimmings would be kept out of both the human and the animal food chains.
         In addition, Mr Hogg explained that he had instructed that existing controls in
         slaughterhouses and other meat plants and in feedmills should be more rigorously
         enforced. He emphasised that if the public accepted ‘the best opinion that we have’
         that beef and beef products could be eaten with confidence, then he believed there
         would be no damage to the British beef market.

         Postscript

         831 This brings the period with which this Inquiry is concerned to an end. We
         should, however, record that on 3 April 1996 Mr Hogg announced to Parliament
         that the 30 month scheme that he had favoured would be put in place rather than the
         deboning scheme that SEAC had recommended. The principal reason for this
         change of policy was that the deboning scheme did not suffice to allay the anxieties
         of the consumer. Furthermore, within 24 hours of the Government’s announcement
         accepting SEAC’s advice, supermarkets made it clear that they would not be willing
         to sell meat from animals aged more than 30 months. A further, though subsidiary,
         problem was that the capacity of deboning plants was not enough to provide for the
         deboning under official supervision of all beef. It may be that a further motivation
         for the change was that it might help to persuade the EU to reverse the ban, which
         it had just imposed, on all British beef.
160
                                                                   PROTECTING HUMAN HEALTH


832 We have asked ourselves whether these problems that confronted the
Government in its choice of policy option could not and should not have been
foreseen. This leads us to the question of the extent to which there was any
contingency planning in the months leading up to 20 March.

Contingency planning

833 At the meeting of the MAFF Consumer Panel, set up by Mr Gummer, of
24 January 1996, MAFF tabled a paper which included details of the recent young
victims of CJD. Dr Godfrey, a member of the Panel, wrote a response, dealing with
what he accepted was the unlikely possibility that they might prove to have been
infected by BSE. He commented:

       If the tiny cluster is due to people having been infected, further cases are
       likely, perhaps many of them. It seems best for government to plan now for
       this highly improbable possibility. This should include: (a) taking statistical
       advice on what will be taken as significant evidence, leading to action; (b)
       what advice should be given to consumers. It should be the aim to get advice
       across to us before the predictable reactions to what would be major tragedy,
       but also a major news story; (c) what action should be taken, in this
       hypothetical situation, to make the beef that could be eaten by consumers in
       the future safe again. This would obviously cost a lot, and be technically
       difficult, but possible.

His observations made sound sense.

834 In his first witness statement to us, Mr Carden gave this account of the reaction
within MAFF to Mr Eddy’s minute of 6 February:

       Those of us who received Mr Eddy’s 6 February report were aware that we
       could be on the edge of a very far-reaching change in the picture we had of
       BSE. My recollection is that from then on until SEAC reached a concluded
       view on 20 March 1996, we felt in a state of high alert. We – I am referring
       to myself and the circle of people within Government to whom the news at
       that state was deliberately confined – paid extremely close attention to each
       new indication from the leading experts. But for more than a month the
       tentative indications from SEAC’s 1 February meeting were all we had to go
       on. The hints of bad news remained tentative, and we lived in suspense.

835 In a subsequent statement, he added:

       Dr Will’s findings were the first firm indications that the balance of
       probability might be shifting in favour of BSE actually being transmissible
       to man (contrary to what had generally been believed in MAFF up till then),
       and that one suspected means of transmissibility – ingestion of beef – had
       suddenly gained ground over the others that had been attracting more
       attention in autumn 1995 . . .

       I and my colleagues in MAFF devoted much time and energy in the first
       months of 1996 to watching every new indication of what was going on;
       we moved into a state of high alert as events unfolded, and discussed and
                                                                                         161
FINDINGS AND CONCLUSIONS


                evaluated each new development intensively; with MAFF and DH in very
                close touch both at official and ministerial level at all key stages.

         836 This is precisely what we would have expected to have happened on receipt
         of Mr Eddy’s minute. We have criticised Mr Eddy for not drawing attention in it to
         the concerns expressed by members of SEAC about the implications of the young
         victims of CJD. Despite this, we consider that the contents of his minute should
         have put those who read it on alert in the manner described by Mr Carden. It did not.
         Mr Carden’s recollection of the reaction to Mr Eddy’s minute is mistaken.
         Whatever impression Mr Eddy’s minute made on those who read it, it did not lead
         any of them to take any action.

         837 Despite the shortcomings in Mr Eddy’s minute, on reading that minute
         Mr Hogg and Mrs Browning should have sought to discuss its implications with
         Mr Packer, Mr Carden and Mr Meldrum. Similarly, on reading that minute, those
         officials, after discussion among themselves, ought to have raised its implications
         with Mrs Browning and Mr Hogg. Each of these five individuals should have
         considered the action that might be required should the scientists advise that BSE
         had probably been transmitted to humans, and they should have recognised the need
         for MAFF and DH to address the implications in conjunction, for example by
         seeking the views of Sir Kenneth Calman and by discussion between Mr Hogg and
         Mr Dorrell. In the event Mr Eddy’s minute seems to have been treated by all simply
         as information on matters that called neither for action nor for discussion.

         838 Mr Hogg told us, on the basis not of recollection, but of reconstruction, that
         he believed that he must have developed his 30 month scheme over a period of
         months, and discussed it with Mr Packer and other officials. Mr Packer gave this
         evidence some faint support when speaking of dim recollections of discussions with
         Ministers and others on a ‘what if’ basis. We are satisfied that there were no such
         discussions about Mr Hogg’s 30 months scheme. Mr Hogg did not decide on this
         until shortly before he presented it to his officials on 18 March. There was no
         discussion between Mr Hogg and his officials prior to 8 March as to the options that
         would need to be considered should it prove that BSE had been transmitted
         to humans.

         839 The position was precisely the same in DH. Sir Kenneth Calman made it plain
         that he was not himself involved in any contingency planning or discussions before
         March 1996. He added:

                After the meeting in February, clearly both the Department of Health and
                MAFF, particularly through Dr Rubery’s Division, were and should have
                been looking at these issues; indeed, as MAFF were; and clearly Ministers
                would be informed, as they always are when things are changing.

         840 Dr Rubery, Dr Wight’s superior, told us that she was worried about the cases
         of CJD in young people. She spoke of having frequent meetings with Dr Roger
         Skinner, a Principal Medical Officer at DH, which reflected her and her
         Department’s growing concern about them. She said that this concern was also
         reflected in ‘many informal discussions with Dr Wight, Dr Skinner, Dr Metters, the
         CMO and the Permanent Secretary’, although she could not recall any further
         details of these informal meetings. We are satisfied that Dr Rubery’s recollection
162      that such meetings took place in February is mistaken. DH was not on a state of alert
                                                                  PROTECTING HUMAN HEALTH


about the implications of these cases prior to March. Mr Dorrell was not even
notified of the findings reported to SEAC at its February meeting. Dr Metters gave
us some additional written evidence after he had appeared in Phase 2 of the Inquiry,
in which he spoke of discussing prevention, care and treatment options with the
Permanent Secretary and with Sir Kenneth Calman in mid-February. We do not
believe that these discussions can have taken place before March.

841 Mr Carden stated that MAFF and DH were in very close touch at both official
and ministerial level at all key stages. We have found that there were no
interdepartmental discussions about the possible implications of the findings of the
CJDSU in either January or February. Indeed, the Departments do not seem to have
started to work together to address these until the meeting called by Sir Kenneth
Calman on 13 March. Even then Mr Hogg proceeded to decide on the response that
he considered appropriate without reference to Mr Dorrell or Sir Kenneth Calman.
When we asked him whether he should not have discussed the 30 month scheme
with Mr Dorrell, he replied:

       No, forgive me, the 30 month rule was down to me; that was my policy;
       it was something for which MAFF was answerable.

842 We have already expressed the view that MAFF officials and Ministers should
have consulted Sir Kenneth Calman when they learned about the content of the
SEAC meeting in February. Equally we consider that when Sir Kenneth and
Dr Metters received Dr Wight’s minute of that meeting, albeit that it was couched
in sedative terms, they should have initiated discussions with MAFF officials to
discuss the implications of the new evidence, and Sir Kenneth should have alerted
Mr Dorrell.

843 What was the reason for the inertia on the part of both Departments prior to
March? Mr Carden gave this answer when asked why there had not been contact
between MAFF and DH after SEAC’s meeting of 1 February:

       I think that both Departments will have been looking to SEAC to bring
       forward a firmer scientific view.

844 It was not merely SEAC’s scientific view that the two Departments were
awaiting. By 1996 the practice had become firmly established of looking to SEAC
to advise on policy decisions – to an extent that came close to delegating them to
SEAC. Witnesses told us that as the Government would not be prepared to take a
decision without the advice of SEAC, contingency planning was a waste of time
until SEAC’s advice had been received.

845 Waiting for SEAC was not a satisfactory alternative to examining policy
options. The choice between those options did not turn simply on matters falling
within SEAC’s areas of expertise. Wider political considerations needed to be taken
into account, and these could well have been identified and discussed, on a
contingency basis, in February. Nor was there any reason why SEAC should not
have been asked to consider the various options that might be adopted to reduce risk
of transmission further, and comment on their efficacy.


                                                                                       163
FINDINGS AND CONCLUSIONS


         What would contingency planning have achieved?

         846 The major policy decision taken on 20 March proved almost immediately not
         to be viable. The deboning option was not acceptable to the market, nor was it
         practicable. This option was recommended by SEAC under enormous pressure and
         instantly adopted by the Government, with no time to consider its implications.
         Mr Hogg took the view that it was not safe to rely on the proper performance of
         slaughterhouse operations to guarantee the safety of food. He wanted belt and
         braces. The supermarkets took the same view. Had MAFF, with the assistance of
         SEAC, begun to consider the options in February on a contingency basis, it is at
         least possible that they would have anticipated the problems which resulted in the
         choice of the deboning option being reversed almost as soon as it was made.

         847 When Mr Dorrell made his statement to Parliament, he was unable to answer
         an obvious question. Were children more susceptible than adults to BSE? All that
         he could say was that he had asked SEAC to advise on this. In the event SEAC
         advised that there was no reason to believe that children were particularly
         susceptible. Contingency planning should have led to the anticipation of that
         question. SEAC could have been requested to answer it. Had its advice been
         obtained before 20 March, parents could have been reassured rather than alarmed.

         848 There is a more fundamental question. One body of opinion considers that the
         over 30 months scheme was an over-reaction and that the risk that BSE was shown
         to pose to humans would have been adequately addressed by SEAC’s deboning
         recommendation. We have asked ourselves whether the announcement of 20 March
         would have come as less of a shock:

            •   if the communication of risk to the public had not suffered from the defects
                that we have described;
            •   if successive CMOs and SEAC had stated plainly that they had growing
                concerns that BSE might be transmissible and that some humans might have
                been infected before the various precautions were introduced; and
            •   if those officials who commented on risk had frankly stated that the cases of
                CJD in farmers and in young persons were cause for concern, rather than
                emphasising that it was safe to eat beef.
         Would the public have accepted that SEAC’s deboning recommendation was an
         adequate response, so that beef from cattle aged over 30 months, removed from the
         bone, could have continued to be sold and eaten?

         849 We have no doubt that had the approach to risk communication been that
         suggested above, the announcement of 20 March would have been less of a shock,
         and the public would not have felt that they had been deceived about the risk posed
         by BSE. But we do not believe the outcome would have been different. In March
         1996 it was not clear how and to what extent the ruminant feed ban and the animal
         SBO ban had cut the rate of infection in cattle. No one knew, or could reliably
         calculate, how many cattle subclinically infected with BSE were entering the food
         chain. The improvement in slaughterhouse standards of removal of SBO was not yet
         clear. We believe that the public would inevitably have shared Mr Hogg’s reaction
         that belt and braces were needed. Even today, over four years on, when these
164
                                                             PROTECTING HUMAN HEALTH


matters can much more readily be evaluated, the Over Thirty Months Scheme
remains in place.




                                                                               165
      7. Medicines and cosmetics

      Medicines

      850 We turn now to the major topic of the safety of medicines and medical devices
      that use bovine tissues. Unlike food products, these did not attract a great deal of
      public attention and debate in connection with BSE. No doubt this was because their
      provenance was far less apparent.

      851 As indicated in Chapter 2, bovine material was used in a variety of ways in the
      manufacture of medicines and medical devices. Some, like insulin, hormone
      treatments and sutures, contained bovine material as an ingredient. Others, in
      particular vaccines, were rather different. Although these did not directly use bovine
      ingredients, bovine material was widely used to grow cells and viruses. This
      material did not form part of the final product, but it was not known if its use at the
      earlier stages of preparation could transmit infection.

      852 Officials speedily realised that medicines might offer a pathway for infection
      either between animals, or from animals to humans. Scrapie had in the past been
      inadvertently transmitted between sheep through a vaccine containing
      contaminated brain material. Pooled pituitary glands used to derive human growth
      hormone had also transmitted CJD between humans. Risk from ‘biologicals’101
      immediately occurred to the Chief Medical Officer (CMO) when he was told about
      BSE in March 1988.

      853 We devote a large part of vol. 7: Medicines and Cosmetics to examining in
      detail the way matters were handled by the medicines licensing divisions in DH and
      MAFF.

      854 There has recently been lively public interest in action on vaccines and the fate
      of existing stocks when their formulation was being changed so as to substitute non-
      UK for UK-sourced material. This interest seems to have been stimulated by the
      documents and statements collected and published by our Inquiry. From the
      documents made available to us, it was not possible to determine precise dates on
      which stocks of vaccines sourced from UK bovine material were used up. Although
      there is no evidence at this stage that medicinal products were implicated in
      transmitting the disease, the possibility cannot be ruled out. Accurate tracing of
      available products would then be helpful. We found frustrating the gaps in records
      and recollections about this.

      855 We recognise that the relevant documents were bulky, highly technical and
      confidential. Witnesses spoke of files piled room high on individual products. The
      paper trail would have been difficult to follow at the best of times. However, matters
      were made worse by defects in the record-keeping systems used at the time that the
      implications of BSE were being considered. Questionnaires had to be sent out to all
      licence holders in 1989 seeking fresh information about the use of animal materials.
      The Medicines Control Agency (MCA) appears to have taken some years to put
166   101
            Biological material used in the production of human and veterinary medicines, and in medical devices
                                                                     MEDICINES AND COSMETICS


matters right and to have had difficulties keeping material up to date. In 1994 it was
discovered that, although the information obtained via the questionnaire had been
recorded on the database, it had not been updated with information from new
licence applications received after that time.

856 We were able to piece together the main bones of the story from contemporary
papers and minutes, together with evidence from witnesses. What follows looks at
the most significant aspects of what happened. It begins with a brief outline of the
medicines licensing system, which is very different from that covering food safety.
Fuller details can be found in Volume 7.

857 We have recently seen papers from DH concerning a review by the Committee
on Safety of Medicines (CSM) of BSE-related issues associated with the use of
seedlots102 in the manufacture of vaccines. It will be apparent that a number of
assumptions made by the CSM are open to question for reasons we have set out in
our Report (see vol. 8: Variant CJD, Chapter 5). We hope that government will look
at the topic again in the light of what we have said.



The medicines licensing system

858 Under the Medicines Act 1968, medicinal products could not be sold in the
UK without a ‘product licence’ from the ‘licensing authority’. The Secretary of
State for Health carried out this role for the UK as a whole in respect of human
medicines and the Minister of Agriculture, Fisheries and Food carried out the
equivalent role in respect of veterinary medicines. In order to be granted a licence,
a product had to satisfy criteria of safety, quality and efficacy. The licensing
authority also had power to revoke, vary and suspend product licences.

859 Licensing decisions on human products were handled on Ministers’ behalf by
officials in the Medicines Division (MD) of DH, and from 1989 by the Medicines
Control Agency (MCA). Those on veterinary medicines were handled in MAFF’s
Animal Medicines Division (part of the Animal Health Group) advised by the
Medicines Unit and the Biological Products and Standards Department of the
Central Veterinary Laboratory (CVL), amalgamated in 1989 as the Veterinary
Medicines Directorate (VMD). These officials were a mixture of administrators,
doctors, pharmacists and toxicologists. Ministers were consulted over controversial
decisions.

860 Individual licensing decisions could be appealed against and legal challenges
mounted. The burden of proof lay with the licensing authority to justify its
decisions. Decision-making thus had to be based on proper evidence and be
demonstrably untainted by departmental and political interests. Officials and
Ministers relied heavily on advice from several committees of outside experts set
up under section 4 of the Medicines Act and known as ‘section 4 committees’.
Many of the members were of great eminence in their field and their advice was
almost invariably followed. This was certainly the case in dealing with BSE.

861 The main section 4 committees that advised on human medicinal products at
risk from BSE were the Committee on Safety of Medicines (CSM), chaired by
102
      Master stocks from which each batch of vaccines is derived                         167
FINDINGS AND CONCLUSIONS


         Professor (later Sir) William Asscher; the Committee on Dental and Surgical
         Materials (CDSM), chaired by Professor (later Sir) Colin Berry; and the Committee
         on Review of Medicines (CRM), chaired by Professor David Lawson. Two
         subcommittees of the CSM played a key role: the Biologicals Sub-Committee
         (BSC) and the specially constituted BSE Working Group (BSEWG), both chaired
         by Professor Gerald Collee. The Veterinary Products Committee (VPC), chaired by
         Professor Sir James Armour, advised on all types of veterinary products.

         862 One source of relevant evidence was information on adverse reactions
         to licensed medicinal products, reported by the medical profession and the
         pharmaceutical industry on yellow cards, which gave their name to the system
         of reporting – the yellow card system.

         863 Informal methods were often preferred to formal licensing action under the
         Medicines Act. ‘Guidelines’ and ‘recommendations’ were issued, with which
         manufacturers were expected to conform. They had the merit of offering some
         flexibility in the light of particular circumstances and avoiding contentious
         litigation. We were told that in practice they were a powerful tool.

         864 By 1987 the licensing arrangements in both DH and MAFF had developed a
         number of weaknesses. Faced with EU deadlines for reviewing ‘Product Licences
         of Right’ (those granted as an interim measure to products already on the market at
         the time that the UK licensing system was first set up), Ministers commissioned
         management reports from Dr N J B Evans and Mr P W Cunliffe about how
         arrangements might be improved. They found that the basic system was sound,
         but a two-year backlog in handling applications was mainly associated with
         understaffing, antediluvian data-holding systems and blurred management lines.
         The subsequent restructuring into Executive Agencies was intended to rectify some
         of the defects but itself caused some transitional turmoil.



         Medical devices

         865 Devices such as heart valves and pericardium patches were not covered by the
         Medicines Act. When BSE emerged, they were the responsibility of the
         Procurement Directorate (PD) of the National Health Service (NHS), which
         operated a voluntary registration scheme for manufacturers. The purchasing power
         of the NHS gave it considerable leverage over manufacturers. The need to consider
         this type of product in relation to BSE was not recognised until February 1989.
         Thereafter officials in PD lost no time in issuing guidelines that paralleled those
         issued to manufacturers of human and veterinary medicines (see below). Volume 7
         recounts the actions they took on the products thought to carry risk. The last two
         such products were dealt with in early 1990 – one company had come into line with
         the guidelines by January 1990, while the other, after unsuccessfully attempting to
         find alternative material, ceased production of its device in April and recalled
         stocks. The response of PD was prompt and adequate.




168
                                                                      MEDICINES AND COSMETICS


Phase 1: the initial response on veterinary medicines

866 MAFF was quick to recognise in 1987 that veterinary medicines using bovine
material might carry a risk, in particular where, as in cattle medication, there was no
species barrier. Mr Wilesmith’s initial investigations of BSE cases had included
medications as a potential transmission agent, but by the end of 1987 he had ruled
this out as not fitting the pattern of cases.

867 However, Dr Little, the CVL Deputy Director responsible for veterinary
medicines, had meanwhile been giving the implications for these medicines some
thought. He went out of his way to attend a meeting on 9 September 1987 of the
BSC (the section 4 subcommittee of the CSM referred to above) in order to see how
it handled a licence application in which possible transmission of CJD was a
concern. We have already noted in Chapter 3 that differing perceptions about what
happened at that meeting were to create an unfortunate misunderstanding between
MAFF and DH about how much thought the latter was giving to BSE. We return to
this below when we look at initial action taken by DH.

868 Within MAFF, Dr Little carried matters forward by commissioning a paper
in November 1987 from a member of his staff, Mr Peter Luff. The paper was
impressive as an initial overview of what was known about BSE in relation to safety
of veterinary medicines. It reviewed options for action. Unfortunately, those
responsible for human medicines were not sent Mr Luff’s paper.

869 The paper was discussed twice in early 1988 by the Biologicals Committee, a
working group of MAFF officials who handled routine biological product
applications. They decided to leave the matter in abeyance for the time being.

870 It was resurrected in June, soon after a special discussion on BSE organised
by Dr Philip Minor of the National Institute for Biological Standards and Control
(NIBSC), and after Ministers’ decision to introduce a ruminant feed ban. Dr Little
and his staff acted swiftly. By 6 July Mr G W Wood of the CVL had prepared a set
of draft guidelines for producers of veterinary medicines using bovine material.

871 These draft guidelines were given in July to NOAH, the trade association
representing veterinary medicines producers, and were discussed with them on
several further occasions.

872 Meanwhile MAFF provided letters of warning both to the Veterinary Record
and to individual practitioners about the dangers of pituitary hormone material
prepared outside the ambit of Medicines Act licensing. The concerns about BSE
coincided with a review of hormone-based products that had Product Licences of
Right. A warning about BSE was issued in general guidance produced in November
and approved by the VPC on completion of the review. By the end of 1988 MAFF
officials were also ready to seek the endorsement of the VPC for the proposed
general guidelines on BSE.

873 All these were admirable initiatives so far as veterinary medicines were
concerned. The problem was that the parallel interest of those dealing with human
medicines had been neglected. Apart from a copy of the MAFF draft guidelines sent
to Dr Harris, the Deputy Chief Medical Officer at DH, in July 1988, at the
                                                                                          169
FINDINGS AND CONCLUSIONS


         suggestion of Dr Minor of the NIBSC, we could find no trace of any significant
         contact between the two licensing authorities about BSE and medicines throughout
         this period.

         874 In December, Dr Paul Adams of DH, who was following up recommendations
         by the CSM on human medicines, had some discussion with Mr Bradley at the CVL,
         and the penny began to drop that MAFF and DH should work together on advice
         about the same biological material forming the basis of both animal and human
         medicines.



         Phase 1: the initial response on human medicines
         875 We have looked at what was happening during the same 18 months within DH.

         The period up to March 1988

         876 As we have already seen, up to March 1988 DH had been neither informed nor
         consulted by MAFF about BSE. We looked at two occasions during the period when
         this might have happened.

         877 The first was the BSC meeting on 9 September 1987, which Dr Little attended.
         Also present was a DH pharmacist, Mr John Sloggem, who had been researching an
         application for a Clinical Trial Certificate (CTC) for a product containing bovine
         brain extract. Fortuitously he had learned of BSE in August from Dr David Taylor
         at the Neuropathogenesis Unit (NPU) in Edinburgh, whom he had asked about the
         risk from ‘slow viruses’. Dr Little told us that he mentioned BSE at the BSC
         meeting, although others present could not remember this. We think it unlikely that
         Dr Little referred to BSE in the course of the formal proceedings in such a way as
         to register with any of those present. Equally, however, we believe that there must
         have been some informal conversation about it between Dr Little and Mr Sloggem
         after the formal meeting was over. From this Dr Little gained the impression that
         DH was aware of BSE and was giving it some thought. He reported this to Dr
         Watson, Director of the CVL, who in turn told the CVO, Mr Rees.

         878 However, matters were not as Dr Little thought. He did not appreciate that
         Mr Sloggem was pursuing his interest individually, on the narrow front of the
         particular application in front of him, and had learned of BSE quite by chance. More
         generally DH was still in the dark.

         879 Had Dr Little taken steps subsequently to follow up his conversation with
         Mr Sloggem, the true state of affairs might have emerged. Although we do not think
         Dr Little is to be criticised for not doing more, once he thought that DH had taken
         the matter on board, we do think it regrettable that the opportunity was lost for joint
         consideration of BSE at an early stage by those responsible for the safety of human
         and veterinary medicines.

         880 We also considered whether Mr Sloggem might have shared the information
         he was collecting more widely at that stage. However, DH had not been formally
         notified about BSE. Mr Sloggem had learned of it only by chance in the process of
170
                                                                   MEDICINES AND COSMETICS


a particular investigation and thought it was a slow virus. It was not incumbent on
him to inform Medicines Division or DH generally about what he had learned.

881 The second occasion on which DH might have been alerted was at a meeting
of the BSC on 6 January 1988, when Mr Sloggem presented his paper about the
product he had been reviewing. This was the first time that a number of those
present had heard of the new disease. The CTC was turned down, partly with the
‘slow virus’ risk in mind. We do not think it unreasonable that the subcommittee
and the officials of MD did not identify any wider considerations.

882 However, we think it was a pity that no system existed to capture information
of the sort acquired by Mr Sloggem on a readily accessible form of working
database. We see such a database about concerns and queries as being of value to
both the licensing authorities.

March–December 1988

Initial action by the CMO and MD

883 We have seen already that DH was formally notified of the emergence of BSE
in March 1988. When the CMO, Sir Donald Acheson, heard about the disease, he
had an immediate concern about the safety of bovine insulin and of vaccines
prepared using bovine serum. No doubt the unhappy story of human growth
hormone was fresh in his mind. He asked his deputy, Dr Harris, who had long
experience of medicines licensing, to seek advice from the NIBSC.

884 It was also agreed that the safety of biological-based medicines was a priority
question for the proposed group of experts – set up shortly thereafter as the
Southwood Working Party.

885 During April officials in MD saw a submission from the CMO to DH Ministers
alerting them to the disease, and minuted one another about its implications. We
were told they knew ‘virtually zero’ at that time about TSEs. They decided to await
the outcome of the Southwood Working Party’s deliberations. Although some
preliminary steps might usefully have been taken in the meantime, such as
searching their database of licensed products, we thought the decision to await the
views of the Working Party was a reasonable response by MD at this juncture.

The NIBSC discussion

886 On 16 May 1988 the NIBSC organised a discussion about BSE to consider
what the disease might mean for medicines using biological material. The meeting
was attended by Mr Wilesmith, the CVL epidemiologist, Dr Kimberlin from the
NPU, Dr Rosalind Ridley and Dr Harry Baker from the MRC’s Clinical Research
Centre, and Dr A J Beale and Dr A J M Garland from Wellcome. Surprisingly, no
one from MD attended. It has not been possible now to unravel why. Dr David
Jefferys, the obvious candidate as head of the new drugs and biologicals branch of
MD, believes he did not receive an invitation. Among the outcomes of the
discussion was a recommendation that tests of the infectivity of calf serum should
be undertaken. We return to this later.
                                                                                      171
FINDINGS AND CONCLUSIONS


         Galvanising MD

         887 In May Dr Pickles, the newly appointed DH joint secretary of the Southwood
         Working Party, moved into action. She summoned up some information from the
         existing database and suggested to Dr Jefferys that a number of questions should be
         put to the BSC. He was not in favour of doing so, noting that the BSC had already
         discussed BSE informally in January. He did, however, respond with some
         preliminary thoughts and suggested that others in MD should also be involved in
         any further discussions.

         888 Dr Pickles returned to the charge on 21 June immediately after the first
         meeting of the Working Party. In a forthright minute intended to ‘galvanise
         Medicines Division into action’, she listed further questions needing answers and
         pressed for these to go to the BSC. Dr Gerald Jones, the senior medical officer in
         MD, told us that by now it had become clear that they had ‘a serious problem’. They
         decided to refer the issue of BSE to the BSC and during July Dr Frances Rotblat,
         a Senior Medical Officer working for Dr Jefferys, and Dr John Purves,
         Pharmaceutical Assessor to the CSM and the BSC, were commissioned to write a
         joint paper for the BSC’s November meeting.

         889 We were concerned whether the matter was put to the section 4 committees
         sufficiently promptly, and whose responsibility this was. One of the defects
         identified by the Evans/Cunliffe report was the divided responsibility in MD and
         lack of clear management lines on many matters. BSE was inherently an awkward
         topic for MD to handle. It had implications across the different administrative,
         medical and pharmaceutical branches and potentially affected both new, and as yet
         unlicensed drugs, and drugs already on the market.

         890 We accept that responsibility for BSE did not naturally fall to a single branch
         within these arrangements, but consider that good management pointed to a lead
         responsibility being assigned. We consider it fell to Dr Gerald Jones, having
         discussed the matter with senior staff, to decide the priority to be accorded to BSE
         in relation to other work within MD and to set in hand appropriate action.

         891 We also consider that he should have asked for the paper to be prepared for
         the September rather than the November meeting. It seemed from the evidence we
         received that, even allowing for the logistics of preparing and distributing papers in
         good time, this could have been achieved had Dr Jones assigned the matter a higher
         priority. The consequence was that two months were lost when progress might
         otherwise have been made.

         The paper for the BSC

         892 The paper prepared by Dr Rotblat and Dr Purves served its purpose. It elicited
         advice from the BSC in November. The subcommittee made a number of
         recommendations, which were to apply to all licences for new products, including:

                i.    No immediate licensing action on oral products.
                ii.   All bovine materials to come from appropriately certified healthy herds,
                      not fed with animal protein. No brain or lymphoid tissue to be used in
172                   parenteral products.
                                                                    MEDICINES AND COSMETICS


       iii. Manufacturing processes for parenteral products to be capable of
            eliminating scrapie-like agents.
       iv. MAIL (Medicines Act Information Leaflet) article to request
           manufacturers to identify products in which bovine materials had been
           used. Serum to come from appropriately certified healthy herds.

893 These recommendations were subsequently endorsed by the CDSM, which
among other things was responsible for sutures, the CRM, which was reviewing all
the Product Licences of Right, and the subcommittee on Safety, Efficacy and
Adverse Reactions (SEAR). They were then endorsed by the CSM itself on
17 November.

894 The Chairman of the CSM, Professor Sir William Asscher, told us that
experience with human growth hormone and dura mater implants had made the
Committee very wary of parenteral products. However, the fact that scrapie had not
transmitted to man gave reassurance that BSE was unlikely to be acquired orally.

Sir Richard Southwood’s concerns about biologicals

895 A copy of the recommendations was sent to Sir Richard Southwood.
Sir Richard had been taking a continuing close interest in the question of the safety
of biologicals. He had written to the CMO in August about this and had been
reassured that the topic would shortly be coming before the CSM and other
committees. He had written to Professor Asscher just before the CSM’s November
meeting pressing for any action to apply then to existing products and making a
number of suggestions for the contents of informal advice to manufacturers.
A round of further correspondence ensued, mainly consisting of Sir Richard’s
continuing concern that he was not getting his point across about existing products,
and Professor Asscher’s replies assuring him that he was. When he gave oral
evidence Sir Richard told us that by existing products, he thought the Working Party
meant products that were already licensed and stocks of those products. It is not at
all clear whether Professor Asscher and the CSM appreciated that the second
category was included.

896 Sir Richard Southwood also wrote in December to Dr Little about veterinary
products, making similar points. It is plain from this letter that Sir Richard was
unaware of the advanced preparation of MAFF guidance.

897 We have already noted that MAFF did not go out of its way to inform officials
in MD, or involve them in the discussions about BSE in MAFF’s Biologicals
Committee. Equally, MD officials did not seek to find out the situation on
veterinary medicines when the issue of BSE and human medicines arrived on their
desks in April 1988, or when the MAFF draft guidelines were despatched to them
in July 1988. The consequence was that DH had to catch up with several months’
head start by MAFF before it could begin to address the problems.




                                                                                        173
FINDINGS AND CONCLUSIONS


         Phase 2: preparing joint guidelines, January–March
         1989

         898 On 3 January 1989 MAFF and DH officials eventually sat down together to
         work out a joint policy towards medicinal products. They agreed it was essential to
         keep in step, especially as MAFF concerns about animal vaccines would cause DH
         great difficulties of supply if current stock – in some cases up to five years’ supply
         – had to be lost. Joint guidelines should be published in MAIL together with a
         request for information. These conclusions were relayed by Dr Jefferys and
         Dr Adams to Dr Harris.

         899 Within MAFF, Mr F J H Scollen, who handled the policy side of veterinary
         medicines licensing in Animal Health Division, minuted Mr Cruickshank with his
         views. He saw the issue as one to be addressed ‘first and foremost in the human
         health context’ because of the risks associated with maintaining or disrupting the
         supply of vaccines for human health purposes. He went on: ‘Judgements about what
         is needed and feasible on the animal medicines front can be more readily taken
         afterwards.’ This was the line that was subsequently taken.

         900 A text for draft joint guidelines was agreed by an ad hoc working group of
         officials from DH, MAFF and the NIBSC, chaired by Professor Collee, which met
         on 1 February. The group decided that further action, especially on current stocks
         of affected products, should be determined once the scale of the problem had been
         more precisely identified with the help of the manufacturers. Any such action
         ‘would need to be based on a human health risk/benefit assessment’.

         The final draft of the Southwood Report

         901 Licensing officials had been keen to know what the Southwood Report would
         say about medicines. They were looking to it to provide reasoned grounds for any
         action they might take. At the 1 February meeting those present were shown the
         currently proposed wording of this section by Dr Pickles, and reacted with dismay.

         902 Mr Scollen, who had attended the meeting, gave a graphic account in a minute
         to Mr Cruickshank:

                There was general dismay at the drafting, which tends to highlight the
                (theoretical) risk via medicines and to relegate the qualification that the risk
                is remote.

         903 After listing a number of criticisms the group had made of the draft,
         Mr Scollen continued:

                Even if the report is modified in the light of these reactions, its appearance
                seems likely to trigger a need for a major public relations job which takes full
                account of the medicines angle. Consistency between MAFF and DH will be
                essential and should be achievable. The guidelines themselves could
                subsequently generate similar pressures since they clearly do not address the
                issue of current stocks and they could prompt questions – for example – on

174
                                                                   MEDICINES AND COSMETICS


      the standards applicable in the collection of animal material at
      slaughterhouses for biological medicinal purposes.

      While I have no doubts about the Working Group’s staged approach and the
      balance to be struck between risks and benefits to human health, this will not
      be the easiest position to present to a potentially critical public prone to
      seeing the influence of commercial interests.

904 Dr Pickles, too, got the message. The next day she wrote to Sir Richard
Southwood reporting:

      They have now realised that virtually none of the current essential human or
      animal vaccines could comply with the CSM guidelines as agreed by their
      November meeting and there may be several years of some vaccines in stock
      to make matters more difficult. Public confidence in the vaccination
      programme must not be put in jeopardy and yet supplies of some vaccines
      are very limited. After a late start, it now seems that both human and
      veterinary sides of the medicines business are working together and putting
      together a package of measures that seem sensible and workable (and indeed
      now incorporate all the points you raised with Professor Asscher in your
      earlier letters, and which I had raised with them separately).

905 She went on to suggest a revised passage for the Report on the grounds that:

      This treats CSM/VPC like HSE ie the problem has been referred to the body
      with the statutory responsibility in that area and it is then for them to take
      appropriate action.

906 The Southwood Working Party went along with this line of reasoning at its
final meeting on 3 February and adopted the revised wording suggested. The report
as finally published said on medicines:

      5.3.3 The greatest risk, in theory, would be from parenteral injection of
      material derived from bovine brain or lymphoid tissue. Medicinal products
      for injection or surgical implantation which are prepared from bovine
      tissues, or which utilise bovine serum albumin or similar agents in their
      manufacture, might also be capable of transmitting infectious agents. All
      medicinal products are licensed under the Medicines Act by the Licensing
      Authority following guidance, for example from the Committee on Safety of
      Medicines (CSM), the Committee on Dental and Surgical Materials
      (CDSM) and their subcommittees. The Licensing Authority have been
      alerted to potential concern about BSE in medicinal products and will ensure
      that scrutiny of source materials and manufacturing processes now takes
      account of BSE agent . . .

      5.3.5 In these, as in other circumstances, the risk of transmission of BSE to
      humans appears remote.




                                                                                       175
FINDINGS AND CONCLUSIONS


         The continuing concern on vaccines

         907 Shortly after the final version of the Southwood Report was agreed, Dr Pickles
         sent a copy to the CMO with a draft submission to Ministers. This draft alerted
         Sir Donald Acheson to the continuing concerns about vaccines. He decided to take
         a personal hand in matters and asked Dr Harris on 9 February to look into the matter
         urgently with Medicines Division. He told us that this intervention was quite
         contrary to his normal practice; he was trying to ‘stir up more activity in the
         Medicines Division’.

         908 Stir up activity he did. On 13 February MD officials met and agreed to carry
         out a telephone survey of all manufacturers of children’s vaccines. They mooted
         a working group of officials and experts to follow matters through, and this
         suggestion led eventually to the setting up of the BSE Working Group.

         909 Twenty-four hours later, MD had collected a useful body of information from
         those manufacturers identifying what they knew about vaccines that contained
         bovine material or which might have used it during manufacture, and about the
         stocks held. This suggested that in some cases considerable stocks were held,
         described variously as ‘large’, five years, and 63,000 litres.

         910 An ad hoc group of experts and officials met again on 22 February. This
         meeting was a key precursor to discussion and advice from the CSM the following
         day. For this meeting the group added to its number several outside experts –
         Professor Asscher, Chair of the CSM, Sir John Badenoch, Chair of the Joint
         Committee on Vaccination and Immunisation (JCVI), Dr Kimberlin of the NPU,
         Dr William Martin (Southwood Working Party member) and Professor M D
         Rawlins, Chair of the CSM subcommittee on Safety, Efficacy and Adverse
         Reactions (SEAR).

         911 Those present at that meeting were told of the information on vaccines
         collected at Sir Donald’s instigation. They considered the Southwood Report, the
         proposed guidelines, a draft questionnaire seeking information from licence holders
         and a draft letter to licence holders. There clearly remained a number of concerns
         about the content of the guidelines and whether they ought to be going out at all. It
         was agreed that the guidelines should be seen as ‘gold standard’ and that this should
         be made clear.

         CSM and VPC approval and the issue of the guidelines

         912 The CSM met the next day and approved the various drafts, including a
         covering letter and also a position statement of its own. This said that the Committee
         had considered the safety of human medicines in the light of the Southwood Report
         and agreed that the risk to humans of infection via medicinal products was remote.
         It said the CSM and the VPC had agreed joint guidelines ‘as a precautionary
         measure, and for the sole aim of seeking to guard against what is no more than a
         theoretical risk to man’. The VPC had approved the guidelines a few days earlier.



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913 The main points covered in the guidelines were:

   •   they applied to all licensed products for injection, application to the eye or
       to open wounds;
   •   no brain, neural tissue, thymus or other lymphoid tissue, placental tissue or
       cell cultures of bovine material should be used in manufacture;
   •   collection techniques to avoid contamination should include no brain-
       penetrative stunning, the use of sterile and disposable equipment, calves to
       be under 6 months, all cellular components to be removed from serum;
   •   sterilisation advice; and
   •   the guidelines applied also to material from sheep, goats, deer and other
       animals susceptible to TSEs.

914 An MCA paper for the Committee drew attention to products already produced
and awaiting distribution. It noted that the questionnaire asked companies about
their stocks and said: ‘The Committee’s advice on this issue will be sought at a later
date.’

915 Ministers were told on 23 February that the CSM and VPC had concluded that
the risk of transmission of BSE through vaccines was remote. To ensure the safety
of medicines, however, guidelines would be going out to producers in March. The
Cabinet took this into account when they discussed the Southwood Report later that
day.

916 The guidelines and questionnaire were issued on 9/10 March by DH. The
covering letter took the wording a stage further by referring to the guidance as ‘a
purely precautionary measure’ and said that it represented ‘a standard that is
deemed to be best practice for the future, and steps should be taken to implement it.
However, it is realised that this guidance may not be fully applicable in all
circumstances.’ MAFF issued parallel documents for manufacturers of veterinary
products on 15 March 1989.

Was the action taken adequate?

917 The guidelines were the single most important step taken to secure the safety
of medicines. They were the only specific protection put in place to guard against
BSE infection via medicines, since the SBO Regulations of November 1989
expressly excluded from staining and sterilisation the material going for
pharmaceutical use. Here we consider how matters were handled between January
and March 1989, looking at:

       i.    the Southwood message and how it was interpreted;
       ii.   whether non-binding guidelines were appropriate;
       iii. the scope of the guidelines; and
       iv. treatment of existing stocks.


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FINDINGS AND CONCLUSIONS


         The Southwood message and how it was interpreted

         918 When discussing the Southwood Report earlier in this volume, we noted that
         the wording the members of the Working Party finally adopted to describe the risks
         from bovine material in vaccines and other injected products failed to convey their
         true concerns.

         919 The potential risks from parenteral injection had been one of the Working
         Party’s most serious worries. They were concerned about existing products and
         existing stocks. Their identification of risk as remote was predicated on action being
         taken to address these matters.

         920 Those preparing the guidelines, on the other hand, believed that the risk even
         before taking any precautions was theoretical and remote. Dr Martin observed to the
         Inquiry that his impression on attending the meeting on 22 February was that those
         on the human medicine side regarded BSE as an animal problem, and considered
         that the Southwood Working Party were being excessively apprehensive.

         921 The Working Party were anxious to avoid a vaccine scare. Nevertheless, as
         discussed earlier in this volume, they should not have allowed their Report to give
         a false impression of their assessment of the risk posed by medicinal products. The
         message that flowed from it was that risk was remote even if no remedial measures
         were taken. This interpretation became the conventional wisdom both inside
         Departments and among medicines manufacturers and others outside government.

         Were non-binding guidelines appropriate?

         922 It could be argued that suspect material could have been cut off promptly and
         decisively had formal licensing action been initiated at once on individual items of
         high risk. We were, however, persuaded by the arguments put to us that guidelines
         were a more appropriate approach. In essence these arguments were that this
         approach was quicker and cheaper, and as effective. We agree that had regulatory
         action been attempted based on an unproven risk, a shoal of legal challenges might
         have resulted.

         Was the scope of the guidelines adequate?

         923 The question here was whether covering parenteral products and those applied
         to open wounds or to the eye was enough: should orally administered and all topical
         products – such as creams and ointments – also have been included in the guidance?

         924 Oral products were carefully considered by the experts who sat on the section
         4 committees. Nothing in the Southwood Report pointed to the need to alter the
         assessments made by them in November and sent to Sir Richard at that time. No
         recommendations were made by the Southwood Working Party regarding
         subclinically infected cattle entering the food chain. We felt that it was not
         unreasonable for the section 4 committees to assume that if it was safe to eat meat,
         it must be safe for humans to eat the minimal amount of bovine material contained
         in oral medicines such as gelatine in capsules.

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925 As for topical applications, the guidance covered the two most obvious risks,
application to open wounds and to the eye. The decision not to include other topical
material at this stage seemed reasonable.

Were existing stocks of injected products treated appropriately?

926 The issues that exercised us most were whether suspect stocks of injected
products should have been immediately withdrawn and how this should have been
handled and presented.

Keeping them in use

927 There were two principal arguments against immediate withdrawal of stocks.
The first was the difficulty of procuring sufficient guaranteed ‘clean’ stocks to
maintain the vaccination programme or provide life-preserving medication. Many
of the contemporary documents and the statements we saw emphasised the
difficulty of replacing stocks overnight. In particular, ‘growing’ batches of vaccines
was a lengthy process. For this reason, stocks tended to be built up and kept for a
number of years ahead.

928 The second argument was that such action risked causing a general panic that
would deter parents from having their children vaccinated, as had happened on
previous occasions over other ‘scares’. Discussing his later concern that the
proposed ban on bovine offal should not raise alarm about pharmaceuticals,
Sir Donald Acheson told us:

       I had in mind a marked and extended previous reduction in the acceptance
       of whooping cough vaccine which had followed incorrect public allegations
       by a scientist that the administration of the vaccine carried a significant risk
       of encephalitis. On the one hand I was aware that during the period 1980–
       1988, due to incomplete vaccination of our population of children, there had
       been 123 deaths from measles and 50 from whooping cough in England,
       together with a many times larger burden of illness and some long-term
       complications. Against this I had to balance a remote risk of a fatal disease.

929 Professor Asscher told us he saw the risk-benefit analysis of existing stocks as
comparatively easy because the risk according to the Southwood Report was
remote, and because vaccines were very important in protecting human health:

       The CSM’s judgement was that the risks associated with interruption of the
       UK vaccination programme were far greater than the potential risk of BSE
       being transmitted.

930 We weighed carefully all the evidence provided to us. It is clear that the
overwhelming opinion of the medical professionals at this time was that existing
stocks should not be immediately withdrawn. Officials in MD accepted this advice
and in our view it was reasonable for them to do so. Experience had shown that
incomplete vaccination of children led to significant numbers of deaths that would
otherwise have been prevented.


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FINDINGS AND CONCLUSIONS


         Handling and presentation

         931 The decision not to withdraw existing stocks immediately gave rise to a
         separate but related dilemma: the question of what information should be given to
         the public about the risks associated with BSE and the continued use of existing
         stocks.

         932 The message in the various Q&A briefs prepared at the time of publication of
         the Southwood Report was that the CSM and the Southwood Working Party were
         agreed that the risk of transmission of BSE via medicinal products was remote, and
         that there was no reason to question the safety of existing stocks.

         933 There was concern that publicity about the steps being taken would create the
         very situation that it was desired to avoid. This raised ethical as well as practical
         considerations, calling for judgement rather than scientific expertise. We believe
         that vaccine scares, like food scares, are likely to be fostered by a belief on the part
         of the public that the full picture is not being disclosed. A decision in an individual
         case not to disclose the full picture in order not to alarm the public is likely to
         perpetuate, in the long term, the distrust that leads to alarmist reaction. We can
         appreciate the short-term attraction, in the case of BSE, of not telling the public that
         there was a degree of concern about vaccines. Taking a long-term view, however,
         we believe that a policy of giving the public full information about risk is, on
         pragmatic grounds alone, the correct one, whether the subject matter is food,
         vaccines, or any other area of potential hazard. If we are correct, the ethical
         requirement must also be one of openness.

         934 We were unable to establish in precisely what terms the decision to go on using
         existing stocks was brought to Ministers’ attention and what express consideration
         they gave to it. It seems to us that it must have been at least implicitly understood,
         if not expressly discussed, at a ministerial level, that there was an issue regarding
         existing stocks of vaccines, and that a decision had been taken that they were not to
         be immediately withdrawn while the guidance worked its way through. However,
         there is no doubt that the decision was not taken at a ministerial level.

         935 When we put to various Ministers the question of whether they would have
         expected to be consulted or informed, we received various answers. Mr Clarke, who
         was Secretary of State at the time, thought that if the experts were agreed, they
         probably need not refer it to Ministers. Mrs Virginia Bottomley and Mrs Edwina
         Currie, who had also served as Ministers in DH, took a different view. Mrs Currie
         added that she would not dream of overruling people who were on the various senior
         medical committees. However, she went on to say: ‘If it was an issue that was likely
         to arouse public concern, for example a dodgy batch of vaccine, then Ministers
         would be alerted very quickly.’

         936 Had the decision in February 1989 about the continued use of stocks of
         potentially infected vaccines and its sensitivity in relation to the vaccination
         programme been explicitly put to Ministers, we believe they would have accepted
         the overwhelming advice of the expert committees, CMO and other DH officials.
         However, we also believe they would have taken a lively interest in how soon the
         doubtful material would be phased out and the steps to encourage this. Such interest
         would have influenced the subsequent pace of events.
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Phase 3: implementing the guidelines after March 1989

937 We look now at the third phase of action and one that has attracted great public
interest. When they put the guidelines to the CSM for approval in February, officials
had emphasised that they were practicable and capable of being implemented over
as short a time period as possible. They now had to ensure this happened. They also
had to deal with the matter of existing stocks, on which they had undertaken to come
back to the CSM. Were these tasks carried out adequately for both human and
veterinary medicines?

The context for handling matters

938 Before we trace the way in which DH and MAFF respectively carried out these
tasks over the years that followed, we draw attention to two significant changes that
took place in the context in which they were acting.

939 The first was the reorganisation of the administrative arrangements for
handling licensing that we have already touched on, in order to create Executive
Agencies. Preparatory changes were made in 1989 with the redesignation of MD as
the MCA and the appointment of a new head from outside the public sector,
Dr Keith Jones. This was paralleled by the appointment of Dr James Rutter as the
head of the newly constituted VMD. After a ‘shadow’ period, during which
reporting lines remained much the same, the two Executive Agencies came into
formal existence in 1991 and 1990 respectively. The Medical Devices Agency
followed in 1994.

940 Although these new arrangements did not alter the way the medicines
licensing system worked, they affected how officials were organised, their
accounting lines and the performance standards they were expected to meet.

941 The second major change was increasing EU involvement in medicines
matters and the handling of BSE risk. European guidelines on BSE and human
medicines came into operation in May 1992 and closely similar ones on veterinary
products a year later. In addition, the World Health Organisation offered a formal
view in November 1991 that the careful sourcing of material was the best way of
securing safety from the remote risk in medicinal products. The international
dimension to medicines dominated the later years covered by this Report.

Collecting and analysing the information

942 The first step for both Departments was to collect the information asked for in
the questionnaires issued in March. The date set for questionnaire returns was
1 May 1989, with a view to discussion at the first meeting of the newly constituted
BSEWG in July. Six weeks proved far too short a deadline. It was to take many
months of chasing to get in all the responses. The delay in getting returns collected
and analysed meant that the first meeting of the BSEWG had to be postponed until
September.

943 Meanwhile work continued within the MCA on analysing the responses. The
different products were ranked according to risk, and MCA officials were asked to
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FINDINGS AND CONCLUSIONS


         prepare papers on those falling in the three highest risk categories for consideration
         by the BSEWG when it met. We thought this was a sound approach. The ranking,
         which was influenced by Dr Kimberlin’s views, and was subsequently adopted by
         the BSEWG, was as follows:

                i.    Injected products with bovine brain/lymphoid tissue as ingredients.
                ii.   Injected products with bovine ingredients other than the above.
                iii. Tissue implants, open wound dressings, surgical materials, dental and
                     ophthalmic products with bovine ingredients.
                iv. Topically administered products with bovine ingredients.
                v.    Orally administered products with bovine ingredients.
                vi. Products with other animal/insect/bird ingredients.
                vii. Products with materials produced from animal material by chemical
                     processes, eg stearic acid, gelatine and lanolin.

         The SBO ban and pharmaceuticals

         944 Meanwhile, as we described earlier in this volume, action in MAFF was
         developing on another front. Mr MacGregor’s decision to introduce an SBO ban
         had initially made DH nervous that this would awaken public concerns about
         pharmaceutical safety and thus threaten the vaccination programme. However,
         Sir Donald Acheson told us that, apart from this anxiety, DH welcomed the
         proposed measure as a step to protect human health. When MAFF set about defining
         the scope of the ban, DH became involved in the process. This was handled mainly
         by Dr Metters, who was Dr Harris’s successor as Deputy Chief Medical Officer, and
         by Dr Pickles.

         945 Dr Pickles quickly spotted that the list of risk tissues included some used
         for medicines and medical devices, such as intestines, spinal cord and thymus.
         However, the approach being adopted was that the SBO ban could not and should
         not apply to material used for pharmaceutical purposes. At a definitive MAFF
         meeting on 27 September 1989 about the scope of the ban, it was agreed that the
         Regulations ‘were not the correct vehicle’ for a ban on non-food items. This was
         consistent with the existing exemption for unfit meat sent to a manufacturing
         chemist, in the 1982 Meat (Sterilisation and Staining) Regulations. In November
         Ministers agreed with the advice put to them that the CSM/VPC guidelines already
         in place were the appropriate safeguard in relation to the use of SBO in medicines.
         Manufacturing chemists should therefore continue to be allowed to receive the
         unsterilised and unstained material.

         946 We noted that when the question of this exemption came up again in
         March 1991, there was a further debate and the position changed. Mr Lawrence saw
         the exemption as ‘rather anomalous’ and argued that it should be removed. MAFF
         Ministers agreed with the proposal and the new Regulations in March 1992
         removed the specific exemption for ‘manufacturing chemists’. However, bovine
         material for pharmaceutical use may have continued to fall within the general
         exemption for premises used for the manufacture of products other than food.
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947 This sequence of events highlighted the differences between the legislative
frameworks for ensuring the safety of food and medicines.

948 We consider the legislative framework in Chapter 14, and examine there the
extent of general statutory powers to ban the use of potentially hazardous bovine
tissues for any purpose which might involve a risk to health, or even to destroy
them. Differing legislative powers made it difficult to adopt a consistent approach
to preventing the use of SBO in food, animal feed, medicines, medical devices and
cosmetics.

949 We recognise that there are different considerations in play, and that much is
dictated by relevant European legislation. However, the different frameworks make
it more difficult to achieve a consistent approach. The most glaringly anomalous
outcome in the case of BSE was the ban on the use of intestines for food purposes
while they might still be used for sutures – thought to be a higher-risk route of
infection.

How the BSEWG operated

950 The BSEWG was set up specifically to advise on the implications of BSE
for human medicinal products. Its membership was high-powered. Chaired by
Professor Collee, it included the chairmen of the section 4 committees it was
advising, together with Dr Tyrrell, Dr Will and Dr Kimberlin of the Spongiform
Encephalopathy Advisory Committee (SEAC) and Dr David Taylor of the NPU.
Any conclusions it reached were therefore going to have great authority. However,
it was purely advisory. It depended on the problematical cases and information
about them being brought to its attention by officials, and on officials’ subsequent
action to follow matters up. Dr A Lee, an official in the VMD, was given the role of
MAFF representative on the Working Group to maintain a link with the parallel
action by the VMD. Altogether the BSEWG met five times between September
1989 and July 1992. These meetings provide convenient milestones, which we
follow below.

First meeting of the BSEWG on 6 September 1989

951 At its first meeting the Working Group considered a list of products identified
by officials from questionnaire returns and other data held. It agreed the ranking of
risk categories proposed by the MCA and considered that the last four gave no cause
for immediate concern. In respect of the first three it made four general
recommendations to the effect that:

       i.    no action was needed where raw materials were sourced outside the
             British Isles in suitable conditions;
       ii.   the guidelines should apply to material from the British Isles, and
             companies should be encouraged to comply as soon as possible. The
             timescale should be agreed for each individual product;
       iii. no licensing action should be taken at present on non-bovine materials;
            and

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FINDINGS AND CONCLUSIONS


                iv. the licensing authority should follow scientific progress on BSE so as to
                    be in a position to take future licensing action when necessary.

         952 The second of these recommendations depended on officials offering the
         encouragement and deciding any timescales. One of the papers put to the BSEWG
         at this meeting gave some indication of their line of thinking about the way the
         exercise should be handled. It suggested that considerations to be taken into account
         included ‘the findings of the Southwood report in which it was stated that “the risk
         to man of infection via medicinal products was remote”. It is important not to
         undermine this considered advice by demanding unnecessary assurances and
         information from manufacturers.’

         953 Officials in the VMD appear to have taken a similar view of the Southwood
         findings. Mr Alastair Kidd told us that manufacturers were advised to change
         sources of bovine materials as quickly as possible, where necessary, but were
         allowed to exhaust existing stocks, as the Southwood Report and the VPC and CVL
         specialists in BSE had considered that the risk of BSE transmission by medicinal
         products appeared remote. The VMD told us that this advice was not given
         generally – the use of existing stocks was considered on a case-by-case basis.

         954 At the BSEWG meeting two types of product were identified as needing
         special consideration. On the first – some homeopathic medicines with Product
         Licences of Right – it was agreed that more information was needed. The CRM
         carried this matter forward and decided in November that no action was necessary.

         955 On the second, surgical sutures, there was a difference of view within the
         Working Group. They had a substantial paper prepared by MCA officials before
         them. Discussions had been taking place for some months with the major UK
         manufacturer about interim measures that might be adopted while a switch was
         made to non-UK material. This was not a simple operation as 25 million metres of
         intestines were used annually. This represented 10 per cent of the annual cattle kill
         in Australia and nearly a quarter of the New Zealand kill. The upshot of the BSEWG
         discussion was that, although the company’s plans for a general switchover (in the
         event begun in February 1990 and completed by the summer) were acceptable, a
         minority thought that the sutures should be excluded forthwith from neurosurgery,
         on which the company itself had envisaged offering a warning. Professor Collee
         was one of these.

         The follow-up to the first meeting

         956 The CDSM opted for the majority view on sutures at its meeting on
         20 September, and the CSM at its 28 September meeting endorsed the BSEWG’s
         general recommendations.

         957 On 10 October Mr Murray Love, an administrator working in Mr David
         Hagger’s division in MCA, minuted Dr Jefferys and others suggesting a way
         forward following the BSEWG meeting. The matters he raised were highly
         pertinent. They included telling firms what the BSEWG had said, timescales for the
         three high-risk categories, dealing with stockpiled products, and the need for a
         coordinated licensing authority approach with clear allocation of responsibility.
         This minute received a lukewarm response from Dr Jefferys, who had discussed it
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with Mr Hagger, Dr Adams and Dr Purves. Their view was that a meeting of the
BSEWG should be arranged for January, and that an in-house procedure for writing
to individual companies about products and setting timetables should be agreed.
Dr Jefferys told us that the follow-up with companies lay with Mr Hagger’s
division. Mr Hagger’s division, however, was already in the process of being
deconstructed as part of the MCA reorganisation.

Second meeting of the BSEWG on 10 January 1990

958 The key issues on this second agenda were the state of play on the 1989
questionnaire and how to deal with products not complying with the guidelines,
particularly the remaining four vaccines which by that stage did not comply.

959 Apart from these vaccines, the only products using high-risk materials were
some allergens using bovine brain in their preparation, not as an ingredient. The
Working Group wanted a tough line on these allergens. The licensing authority
should insist on a changeover to Australasian material within a reasonable
timescale. It was reported that discussions were still continuing at the time of the
next BSEWG meeting in July 1990. In October 1990 officials reported that
satisfactory progress had been made. We were unable to ascertain when a final
outcome was obtained.

960 On vaccines, Dr Rotblat now had more concrete information than that obtained
from her ring-around 11 months earlier. She identified four products, the first three
of which were produced by Evans Medical and the fourth by Wellcome:

       i.    MMR (measles, mumps and rubella) vaccine with stocks to
             December 1990 – not yet licensed
       ii.   Measles vaccine with stocks to September 1990 – not used much now
       iii. Tuberculin PPD with stocks to September 1991 – no other source
            available
       iv. DTP vaccines (diphtheria, tetanus, pertussis) with unadsorbed stocks to
           May 1991 and adsorbed to June 1990 – adsorbed used in preference to
           unadsorbed (not used much now).

961 The meeting decided that ‘the benefits accruing from continuance of the
vaccine programme outweighed the very remote risk to the population from the use
of bovine material in these products’. The minutes go on to say:

       It was considered after some discussion that negotiations should take place
       to ensure that sources are changed as soon as possible and to replace existing
       stocks with new material whenever feasible. Replacement of Wellcome
       unadsorbed DTP vaccine, by Wellcome adsorbed vaccine should ensure that
       the former, which is not much used, is replaced earlier than 1991. In the case
       of the Tuberculin PPD, no other source is available at present, but the
       company (Evans) should be asked to move over to the new product and
       replace stocks as soon as this is feasible.


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FINDINGS AND CONCLUSIONS


         The follow-up to the second meeting

         962 The CDSM, at its meeting on 17 January, praised the speed with which the
         company making sutures had responded to the BSEWG recommendation: it was to
         begin the changeover in February to Australasian sources.

         963 Concerns about BSE in bovine insulin were raised that spring by the British
         Diabetic Association. Dr Jefferys told the Association in April 1990 that none was
         being sourced from the British Isles. Although 42 licensed bovine insulin products
         had been originally identified for the CSM in 1988, none figured among the items
         put to the BSEWG in the light of the questionnaire. We infer that they were by then
         sourced outside the UK.

         Third meeting of the BSEWG on 4 July 1990

         964 Professor Collee told us that at this meeting the Working Group discussed the
         safety of foetal calf serum at length. He had sought the advice of Dr Taylor of the
         NPU and others before the meeting. The Working Group reiterated its view that
         the risk relating to serum was low. Taken together with the fact that the risk of
         transmission of BSE was theoretical and the view that the benefit of availability of
         vaccines outweighed any potential risk from their use, the use of foetal calf serum
         in the process of manufacture was accepted.

         965 The Working Group returned to the issue of the non-complying vaccines.
         Correspondence with the two companies concerned had produced updated
         information.

         966 The Working Group decided that a licence should not be given to the first
         product (unlicensed MMR vaccine) unless it complied with the guidelines, and that
         existing trial batches should not be used.

         967 There was still no alternative to the third product (Tuberculin PPD), which
         used glycerol beef broth during the process of manufacture. Stocks were available
         up to September 1991. These would be changed over ‘as appropriate’ as the new
         supplies, which were peptone-based, came on stream. The Working Group thought
         that the replacement of stocks should take place as quickly as practicable, but
         meanwhile, given the low risk from glycerol broth, the danger of having no stocks
         outweighed the risk from the product.

         968 The source of the measles vaccine was being changed to New Zealand and
         present stocks would be depleted in three months.

         969 The company preparing DTP vaccines had changed the source of its bovine
         media, but meanwhile was still using non-complying material. The Working Group
         recommended a meeting with the company to discuss bringing forward the time
         when there was compliance with the guidelines.

         970 The safety of topical products was also reviewed at this meeting, in the light
         of action taken earlier that year on cosmetics. The only two products using bovine
         material sourced it from West Germany, and it was decided that no further action
         was needed on licensed topical products.
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Fourth meeting of the BSEWG on 31 October 1990

971 This turned out to be the main ‘wash-up’ meeting of the Working Group.
They unanimously decided that the special circumstances of the experimental
transmission of BSE to a pig did not warrant a fresh look at porcine material.
On allergens, they were told that progress with the company concerned was
satisfactory.

972 By now the last of the replies to the questionnaire had been received, some
18 months after they had been sent out, and gave no cause for concern. On the
outstanding issue of the stocks of the DTP vaccine, the Working Group was
beginning to take a more hawkish line. The stock-out dates for the adsorbed
vaccines were now between June and December 1991. Those for the unadsorbed
vaccine ran beyond 1991. The Working Group asked its secretariat to explore with
the licence holder whether the stocks of the latter could be replaced sooner.

Veterinary products

973 On the veterinary side assurances were still awaited from some companies that
appropriate action had been carried through. The BSEWG had received progress
reports from Dr Lee at each of its meetings, although this item appears to have been
treated as purely for information. The difficulties and delays experienced by the
VMD over collecting returns, clarifying obscurities and phasing out certain
products had broadly mirrored those on human products. We note that when the
VPC had its second and final discussion about the exercise in December 1990, there
were at least two companies with considerable stocks of vaccines expected to last
another four years. The VMD provided us with a table outlining the 143 products
that did not initially comply with the CSM/VPC guidelines and the outcome of
compliance measures taken. This indicated that apart from one fish vaccine, all
manufacturers had complied with the guidelines, so far as their manufacturing
processes were concerned, by 1992.

Final meeting of the BSEWG in July 1992

974 After its meeting in October 1990, the BSEWG lay fallow for almost two
years. One or two proposals for a meeting came to nothing. BSE did not figure on
either the CSM or BSC agenda. However, in July 1992 what proved to be the final
meeting of the BSEWG was held. The Working Group considered the implications
of the emergence of BSE overseas for medicines, in particular sutures from France.
By now there were European guidelines in place for human medicines. These were
in some respects a little looser than the UK guidelines, though based on the same
principles. They did not, for example, cover sutures. The BSEWG view was that the
UK should treat sutures as if they were covered by the guidelines even though other
countries did not do so.

975 Once again, concerns about foetal calf serum were raised, with Professor
Collee stressing that continued vigilance was necessary. Besides the unanswered
question of whether it could in itself transmit infectivity, there were also concerns
about collection methods. These concerns were similar to those raised by Dr Pickles

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FINDINGS AND CONCLUSIONS


         some three years earlier and referred to by Mr Scollen in his report to
         Mr Cruickshank in February 1989.

         976 One item that does not appear to have been raised at the meeting was the safety
         of gelatine. Dr Minor had suggested shortly before that it might be discussed there.
         He had been disturbed to learn at a meeting in Heidelberg about the ‘shockingly
         mild’ German manufacturing process after ‘any old cow bone went into the
         production vat including spine and skull’. There was a pharmaceutical interest in
         gelatine because it was used for capsules as well as in some other forms. The matter
         was in the event followed up by a written opinion being commissioned from
         Professor Collee. His advice was that the BSE guidelines on sourcing should apply
         to gelatine. Dr Purves told us that this was taken into account in dealing with
         product licences subsequently. Problems over gelatine rumbled on thereafter, with
         British suppliers taking steps to exclude UK material in order to meet increasingly
         rigorous demands from their overseas customers.



         Overview of the way the guidelines were implemented

         977 We discuss at some length in Chapter 6 of Volume 7 some features of the way
         in which phasing out existing products was handled and the reasons for this. We
         note in particular three factors that directly influenced the response:

                i.    Uncertainty about the risk. Officials and expert committees had to
                      operate mainly on the basis of value judgements, unable as they were to
                      assess and cite proven adverse reactions.
                ii.   The management situation. The heavy task of conducting a case-by-
                      case approach was superimposed on a creaking system that was
                      overloaded and understaffed. Meanwhile the licensing divisions were
                      undergoing restructuring and had new management preoccupied with
                      other pressing tasks.
                iii. Mixed messages about the urgency. The general perception after
                     February 1989 was that although the measures were in themselves quite
                     drastic, they did not have to be treated as an emergency given that
                     Southwood assessed the risk as remote. The low-key presentation of
                     risk, carefully crafted to avert public alarm about the vaccination
                     programme while remedial action was being taken, had the unfortunate
                     result of being taken as the message itself. This must also have
                     influenced manufacturers’ attitudes.

         Veterinary medicines

         978 In the case of veterinary products, a decision was taken that the VMD should
         pace and match its action to that of the MCA. Although we thought this was a
         reasonable approach, it seemed, unfortunately, that playing second fiddle was one
         of the factors that led to a less urgent and decisive approach than was originally
         envisaged. We are in no doubt that a further factor was that, like the MCA, the VMD
         read the Southwood message as basically reassuring. Whether the decisions on
         veterinary medicines had an impact on the numbers of BSE cases may never be
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                                                                     MEDICINES AND COSMETICS


known. It is impossible to say today whether continued use of bovine-based
medication may have added to the total number of BABs.

Human medicines

979 In the case of human products, the problems in tackling the exercise were
greater and the organisational arrangements more complex. The lack of an obvious
lead branch in MD continued in the MCA. While there was a team effort, this lacked
leadership to prescribe what it was expected to achieve overall and who was to do
what by when. Matters were not helped along by changing responsibilities during
the process of integrating the administrative and professional branches.

980 The BSEWG was a useful means of achieving speedy advice from the key
experts. But the Working Group relied on the MCA to refer matters to it and to act
appropriately after receiving its advice. It did not itself lay down any imperatives,
such as deadlines for action to be completed, other than to urge that things be done
‘as soon as possible’ in some cases. Officials were not accountable to it. However,
once the BSEWG ceased to meet, the impetus for officials to prepare progress
reports appeared to disappear.

981 The three most sensitive groups of products used for humans were (i) those
containing brain and other high-risk tissues as an ingredient, (ii) sutures and (iii)
vaccines. We concluded on these as follows:

   •   Products directly containing high-risk tissues, eg brain and glands: the
       small number of products concerned were identified and dealt with
       reasonably promptly.
   •   Sutures: discussions were promptly and effectively conducted with the
       major UK producer, safeguards introduced and use of UK materials phased
       out as speedily as practicable. The experts’ recommendations on sutures for
       general use were reasonable. On the specific question of continuing use in
       neurosurgery, we think with hindsight that it would have been preferable if
       the minority view among the experts that this should not continue had
       prevailed. We note, however, that as yet no cases of vCJD appear to be
       associated with their use.
   •   Vaccines: bovine material was not an ingredient in the finished product.
       What was unclear was whether its use as a growth medium for cells allowed
       infection to transmit. Results of studies on serum carried out by the NPU in
       which no infectivity was detected were not available until 1993. The general
       view before then was that this was a very low-risk material and that there was
       in any event only a remote risk of the BSE agent passing to humans via
       medicines. Given this, and the dangers of interruption to the vaccination
       programme, we think it was not unreasonable to conclude that the balance of
       risk to benefit favoured using the existing vaccines until alternative supplies
       became available.

982 The corollary, it seemed to us, was that the replacement process needed to be
as speedy as possible. While the individual decisions taken by DH about each of the
products concerned were reasonable, it can be seen with the benefit of hindsight that
they contributed overall to a protracted process of achieving compliance with the
                                                                                         189
FINDINGS AND CONCLUSIONS


         guidelines. Parallel delays were incurred in the treatment of veterinary products. It
         seems highly unlikely that so long a period of grace was envisaged by those taking
         decisions on vaccines in February 1989. Knowing what is now known, a harder line
         might have been taken to reduce the length of time that both people and animals
         continued to be exposed to suspect products. Although this is in part attributable to
         the false impression on risk, there was undoubted room for improvement in the way
         the guidelines were followed up. In particular we think it would have been better if:

                i.    there had been a handling plan with well-defined leadership that
                      ‘managed’ the whole process to specific deadlines; and
                ii.   there had been clear expectations about reporting to top management
                      and Ministers. We believe Ministers should take a lively interest in what
                      is being done in their name, and that there should be clear presentation
                      to them of important policy decisions.

         983 We have noted that, once medical devices were identified as a concern, action
         to ensure their safety was handled purposefully. The PD style of administrative
         approach (see paragraph 865 above) might with advantage have been mirrored
         elsewhere and have led to a brisker momentum in phasing out suspect products.

         984 Taking animal and human medicines as a whole, matters that were handled
         well included the heroic venture of a questionnaire to all licence holders to make
         good the faults in the database. Despite believing that action was purely
         precautionary, officials worked diligently to carry the follow-up action to its
         conclusion. The most urgent items were identified and dealt with promptly. A
         voluntary total switch of sourcing was secured, despite there being no firm evidence
         to offer of human risk. All this was achieved while struggling with the legacy of
         serious past failings in the running of the licensing system that were still being
         addressed.



         Research into pharmaceuticals

         985 As the story of the way medicines, and in particular vaccines, were handled
         has shown, there was a pressing need to establish whether bovine serum was
         infective. The only way to do this was by research. In Chapter 7 of Volume 7 we
         look at what happened to proposals for research into this.

         986 The need for this research had been identified at the NIBSC discussion in
         May 1988, though it appears that no studies into the infectivity of serum were
         carried out as a result of this meeting.

         987 However, the subject was not forgotten. When the Tyrrell Committee prepared
         its Report on research in spring 1989, one of the items it identified as a top priority
         was research into which bovine tissues were infective. Given the limitations on the
         numbers of animals, staff and suitable housing to carry out this research, the
         Committee agonised over which items should be done first. In its Report it said:
         ‘Nowhere else has the decision on priorities been more difficult.’


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                                                                     MEDICINES AND COSMETICS


988 The decision it reached included ranking work on foetal calf serum and bovine
serum albumin as a three-star (ie, top) priority.

989 In Chapter 7 of Volume 7 we trace the events that followed after the Tyrrell
Report was presented to MAFF and DH. The proposal had a chequered history. In
August 1989 Mr Gummer proposed and Mr Freeman agreed that it should be jointly
sponsored and funded by both Departments, reflecting their joint responsibilities
under the Medicines Act. Money was earmarked. However, following the first
BSEWG meeting in September, Dr Pickles indicated to Mr Hagger that the MCA
might want to consider whether the work was still needed, given that the action
agreed by the BSEWG should ensure that contaminated material would not be
entering pharmaceutical processing. She pointed out the need to secure Dr Tyrrell’s
support for such an approach. In January Dr Pickles informed Ministers, at the time
the Tyrrell Report was being published, that the MCA was acting on the
recommendation together with its experts.

990 When Mr Lawrence circulated a chart showing progress on the Tyrrell
recommendations in April 1990, he noted that work on serum research was being
carried out at the NPU with industry funding, adding that trade restrictions and
industry sourcing from outside the UK had lowered the priority on research into
serum.

991 It is plain now that MAFF and DH had to an extent been operating at cross-
purposes. DH had been concentrating solely on the proposal allocated to it, namely
to secure research on serum. The Tyrrell Report had identified this item as just one
element in the general programme of tissue testing. That other general work was
being taken forward by MAFF and the NPU.

992 Mr Bradley of the CVL had reached the judgement in December 1989 that
foetal calf serum was one of the top priority items for the limited animal resources
available. The CVO agreed with him and it was included in the quota of tissues for
transmission studies in the first year of the project with the instruction that it was
important to get these studies under way as soon as possible. MAFF emerges with
credit for its purposeful handling of the matter.

993 The work was done by the NPU and the results were made available in 1993.
No infectivity was shown in these tests of foetal calf serum.

994 Thus despite its apparent downgrading by DH, the work was actually done.
However, it seemed to us that this outcome was in some respects achieved despite
inconsistencies in approach and a degree of mutual misunderstanding. Four features
struck us as having complicated the process:

   •   The notion that industry might voluntarily sponsor and share the results of
       the work.
   •   The compartmentalising of the serum and other tissue study items, first
       by the Tyrrell Committee and then by MAFF, in how they allocated
       responsibilities. This led to confusion about how the work was carried out
       thereafter and who was calling the shots.
   •   The detached attitude of the medicines licensing divisions, which had an
       interest in the outcome.                                                          191
FINDINGS AND CONCLUSIONS


            •   The divergent perceptions of MAFF, DH and SEAC about what was actually
                happening on the Tyrrell proposals.



         Cosmetics and toiletries

         995 We have grouped our material about the risk of transmission of BSE from
         cosmetics and toiletries in the same volume (Volume 7) as medicines because these
         products had much in common. In particular, both might apply animal materials to
         the skin, the eye or to mucous membranes. But, as we shall see, they were covered
         by a very different set of safety provisions.

         The main products

         996 Cosmetics using bovine materials fell into three categories. Those most likely
         to present a risk of BSE contamination were some ‘exotica’. They included anti-
         ageing and anti-wrinkle creams and ‘cellular extracts’ such as premium face
         creams. They might contain only lightly processed brain extracts, placental
         material, spleen and thymus. This was the most urgent category to tackle.

         997 The second category consisted of ‘High Street’ topically applied products such
         as creams and toiletries applied to the skin, lips and eyelids. It also included items
         like soaps, shaving sticks and stick deodorants. The bovine materials used were
         heavily processed. Although questions were asked about ensuring the safety of this
         group of products, they were never considered a serious risk.

         998 The third category of concern was bovine collagen used in implants.
         Dr Pickles was concerned initially about their use in unlicensed clinics as beauty
         preparations. We looked into their status. DH told us that in practice this material
         was used under medical supervision and thus treated as ‘prescription only
         medicines’. We concluded that we need not explore their cosmetic use separately.

         Regulation

         999 The Department of Trade and Industry (DTI) had regulatory responsibility for
         the cosmetics industry. At the time BSE emerged, Mr Richard Roscoe, who was a
         Grade 7 officer, headed the branch in charge of the safety of cosmetics sold in the
         UK. DTI looked to DH, and in particular to Dr R J Fielder, for advice about toxicity
         of products that were causing concern.

         1000 The legislation governing safety was the EU Cosmetics Directive and
         Regulations made under the Consumer Protection Act 1987. We set out details of
         these provisions in Volume 7. Although cosmetics had to meet various safety
         requirements, they did not require a licence. Enforcement lay with local authority
         Trading Standards Departments, which would require some evidence of harm
         before seeking to intervene. The Secretary of State for Trade and Industry also had
         certain intervention powers. In practice the regulation of the industry operated very
         much on an informal and voluntary basis, relying on the industry to cooperate.

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1001 Although identified in the Tyrrell Report in June 1989 as needing
consideration, the cosmetics industry received no advice or guidance until February
1990. We deal briefly first with how this happened. We then look at what happened
thereafter.

The Tyrrell recommendation on cosmetics

1002 The Tyrrell Report submitted in June 1989 had this to say about cosmetics:

       Some uncertainty remains as to whether all the possible routes of
       transmission from bovine (and ovine) tissues to other species have been
       considered and appropriate action taken. Small scale users of bovine
       products such as the cosmetic industry, may not be covered by the present
       regulations and guidelines.

1003 Coupled with a wider proposition about investigating the fate of bovine
products passing through as yet unrecognised routes, this item was given a three-
star recommendation for further work. We return later to what happened to this
wider proposal for an audit of bovine tissues.

1004 Despite what the Report said, no steps were taken by MAFF or DH to contact
DTI about cosmetics. By good fortune, Mr Roscoe at DTI learned of the possible
risk from BSE and independently decided to ask DH about it in January 1990. After
he had consulted medicines licensing officials and Dr Pickles, Dr Fielder provided
advice to Mr Roscoe. The gist of it was that DTI should warn the cosmetics industry
via its trade association, the Cosmetic, Toiletry and Perfumery Association (CTPA),
that it should reformulate products so as to exclude bovine offal or source it from
outside the UK.

1005 This Mr Roscoe promptly did. The CTPA in turn relayed this advice in full,
first to those of its members that made ‘premium skincare products’ (the ones most
likely to contain offal extracts), and second to members generally. Ms Marion Kelly
of the CTPA told us she was confident from members’ replies at the time about
premium face creams that no products were using UK material. Replies to a request
for information from the wider membership had not been retained.

Was the initial action adequate?

1006 We considered first the failure to alert DTI in 1989 to the need to consider
cosmetic products in relation to BSE. We think that Dr Pickles, who had the lead on
BSE in DH, should have done so. We were not impressed with her argument that
the risk had been ‘so slight that effectively it could be disregarded’. This ignored the
need to inform DTI as the regulatory Department and the fact that she could not
have known which products were involved.

1007 Throughout the BSE story, Dr Pickles took many prompt and commendable
initiatives to alert those concerned and to carry action forward. Sadly, in this case,
Dr Pickles fell short of her normal high standards. She acknowledged to us that had
she informed DTI, it could have addressed the issues six months earlier than it did.

                                                                                           193
FINDINGS AND CONCLUSIONS


         She should have done so; but this lapse is minor in comparison with the
         commendable action taken by her in many other respects.

         1008 Within MAFF, we considered that responsibility for informing DTI lay with
         Mr Lowson, the head of Animal Health Division. We were not persuaded by
         Mr Lowson’s argument that he had only a hazy notion of DTI involvement in the
         cosmetics industry and that this was a human health matter so ‘something where one
         would expect other Departments to take the lead, particularly the Department of
         Health’. In our view Mr Lowson shared responsibility with Dr Pickles for ensuring
         the recommendations were properly assessed and followed up. We consider that,
         jointly with Dr Pickles, Mr Lowson should have promptly ensured that what the
         Tyrrell Report said on cosmetics was drawn to the attention of DTI. The failure to
         do so contributed to several months’ delay in initiating action to secure the safety of
         cosmetic products.

         Was DTI action adequate?

         1009 Mr Roscoe deserves credit for registering that BSE might pose problems for
         the cosmetics industry, and for acting promptly in seeking advice from DH, and
         passing it on to the CTPA. We agree that the Department’s statutory powers to
         intervene were not appropriate in these circumstances and that the only realistic
         course open to DTI was to persuade the industry to take voluntary action.
         Mr Roscoe’s letter and the response by the CTPA were together the most significant
         single action taken to address the risk from cosmetics.

         1010 However, we think it is unfortunate that Mr Roscoe did not make efforts to
         contact firms which were not members of the CTPA. It was indeed, as he said, a
         ‘flaw in the system . . . that we could not reach all manufacturers’.

         Action taken thereafter

         1011 We turn now to the way matters were handled after the CTPA had distributed
         the DTI warning. Initially, everything went quiet. Dr Pickles had included a
         question about the adequacy of the action taken on cosmetics in a draft paper for the
         first meeting of SEAC in May 1990, but Mr Meldrum raised some concerns about
         the paper, and it did not go forward.

         1012 Three members of SEAC, Dr Tyrrell, Dr Kimberlin and Dr Will, attended the
         meeting of the BSEWG in July 1990, at which the DTI action on cosmetics was
         noted, and topical medicinal products were again given the all-clear.

         1013 However, SEAC itself did not turn to cosmetics until March 1991, when it
         asked for a paper on the topic. This task fell to Mr Murray, who had taken over from
         Dr Pickles as the DH secretary to SEAC. Mr Murray asked one of his staff to make
         enquiries of the CTPA into the use of bovine material in cosmetics. It was unusual
         not to approach DTI as the Department responsible for cosmetics safety.
         Mr Murray’s paper identified the uncertainties about the use of bovine material in
         cosmetics, and about small-scale producers that were not members of the CTPA.


194
                                                                      MEDICINES AND COSMETICS


1014 SEAC discussed Mr Murray’s paper in July 1991, along with a paper from
Dr Pickles about non-food uses of bovine material more generally. The Committee
thought that in general no problems arose, but asked that DTI be reminded of the
need to update the guidance to cosmetics manufacturers in the light of the
emergence of BSE in other countries. After the meeting, Mr Murray asked
Dr Pickles for her view on updated guidance, and she queried whether ‘fringe’
cosmetics companies were being kept informed by DTI, and advised Mr Murray,
when writing to DTI with the guidance, to ask to be told about what happened
thereafter.

1015 Although Mrs Diane Whyte in DH drafted a letter to Mr Roscoe, it appears
not to have been sent. Work continued somewhat slowly on the text of a draft letter
to revise the guidance, but no contact was made with DTI. Meanwhile Mr Bradley
of the CVL had told Mr Lawrence with some perspicacity that ‘contacts via DH/
DTI do not inspire me with confidence’. He felt that MAFF needed either to go out
to the industry to assess what kind of bovine material was really used in cosmetics
and for what, or to have closer contact with the trade association. He observed:

       I am not satisfied yet that the industry is in the clear and it is us that may
       shoulder some blame if it is later found ladies are rubbing cow brain or
       placenta on to their faces.

1016 DH, as it happened, shared Mr Bradley’s view that they needed hard facts
about the situation, and matters now took a different turn. DH had drawn attention
to the lack of knowledge in its paper for SEAC. This led the Department in early
1992 to decide to put a series of detailed questions to the industry to clarify the
situation and what action was being taken. The plan now was that, depending on the
outcome, a meeting with the CTPA might be arranged, and, if need be, guidance
considered later. DH officials did not consult DTI about these ideas. Although the
object was sound, the exercise proved abortive. It was simply impracticable for the
CTPA to provide answers from its members within three weeks to a list of 20
detailed questions asked out of the blue. There was no obligation on the industry to
provide such information.

1017 However, the CPTA did put a note in the May edition of its scientific
newsletter to say that an enquiry had been received from DH about the use of bovine
and ovine materials, and asked any of its members using these to contact the
Association urgently. There was no positive response from CTPA members.
Ms Kelly told us she read this as meaning the members were not using such
materials.

1018 The CTPA’s response led DH to press ahead instead with efforts to draft the
guidance letter originally called for by SEAC a year earlier. In July, Dr Fielder who,
besides being the toxicological adviser to DH, was a UK member of the EU expert
committee on cosmetics, took a hand. He pointed out that there was a risk of getting
into deep water with the European Commission if they sought a voluntary ban. He
suggested a meeting involving DTI before the CTPA was contacted again. This was
a timely proposal. Among other things, it brought DTI back into the frame.

1019 A meeting was held in September 1992 between officials from DH, DTI and
MAFF and CTPA staff and members. There was a useful exchange of information.
The outcome was agreement that DH would provide advice to the CTPA on                    195
FINDINGS AND CONCLUSIONS


         gelatine; the CTPA would list products using risk materials; the CVL would offer
         advice about suppliers of material; and the CTPA would consider further what
         guidance might be prepared. Dr Wight had called this meeting to bring the parties
         together as suggested by Dr Fielder, but it was not clear whose call it was next. The
         initiative on preparing guidance had now been passed from government, whose job
         it was to ensure the safety of cosmetics, to the trade association which would be
         disseminating it.

         1020 However, there was some follow-up contact by telephone and letter. The
         CTPA subsequently wrote to Dr Wight at DH to say that it had contacted a company
         using cerebrosides and that this material would be phased out by early 1993.

         1021 From this point on, action moved to the European arena, with DTI in the lead.
         Before long the EU Working Party on Cosmetics became involved, with a view to
         preparing guidance at the European level. The DH reaction was that this was
         welcome as it helped to avoid the impression that the problem was solely one for
         the UK cosmetics industry. However, Dr Fielder flagged up the danger that the
         exercise might drag on, when in fact guidance needed to go out as soon as possible.

         1022 Dr Fielder’s fears were realised – the exercise did indeed drag on. Preparation
         of European guidance became embroiled in slow procedures, infrequent meetings
         and national differences of view. COLIPA, the European trade association, played
         an active role providing reassurance that voluntary action had been taken.

         1023 In March 1994, at the EU Health Council, all Member States except Germany
         supported the view that existing measures to contain BSE and protect public health
         were sufficient. It was eventually decided that the Cosmetics Directive need not be
         amended to ban the use of bovine material. It was later amended, after the period
         covered by this Inquiry and the emergence of vCJD.

         1024 Meanwhile the CTPA had told DTI that it would prepare UK guidelines
         jointly with the French industry. The CTPA guidance to UK manufacturers was
         eventually issued in March 1994. It followed closely guidance from the World
         Health Organisation that had been issued in 1991 on inactivating TSEs and
         categorising tissues into four categories of infectivity. It is difficult to see how
         much, if any, value was added by the long delay.

         The adequacy of the response

         1025 A problem in assessing the adequacy of the response is the lack of knowledge
         that persists today about what cosmetics that contained bovine ingredients were on
         offer at the time and what precisely they were used for. With hindsight, we agree
         with Mr Bradley’s view that first-hand knowledge needed to be sought. We revert
         to this matter in Chapter 9.

         1026 We recognise the handling problem created by the limited powers available
         to deal with an unproven threat like BSE which affected raw materials. We have
         commented elsewhere on the desirability of statutory powers to destroy dangerous
         material at source.

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                                                                    MEDICINES AND COSMETICS


1027 Given these considerations it can be seen with hindsight that two things were
needed.

1028 The first was purposeful leadership. There was continuing vagueness about
who was in the lead. This confusion operated both between Departments and within
DH. We are in no doubt that the lead should have lain with DTI, with professional
advice from DH. Dr Pickles’s instinct that DTI should be asked to carry forward the
guidance and required to report progress was sound.

1029 The second was a sense of urgency. This was patently lacking. DH thought
the risk was remote. Dr Wight told us that when she arrived in DH in 1991 to take
over from Dr Pickles, she understood that all the significant action on BSE had by
now been taken and her role was principally a watching brief. The perception that
revised guidance for cosmetics was urgently needed and that certain matters needed
to be vigorously followed up had faded away. Manufacturers were left to use up
stocks, and checks were not made to ensure that they had reformulated their
products.

1030 Taken together, the effect was to leave large gaps in knowledge and to delay
inordinately the issue of further advice. As with medicines, this has left unanswered
questions about the products affected, how long production continued and on what
scale. It seems to us undesirable that so little is known about products which offer
a potential pathway to infection. This is a matter we believe DTI should review.




                                                                                        197
      8. Occupational risk
      1031 We turn now to the important matter of occupational risk from BSE. This
      largely escaped the limelight, save briefly when it seemed that farmers might be
      particularly vulnerable to CJD. Contact with live animals and with their tissues was
      a well-known disease hazard. One of the early steps taken by MAFF was to issue
      detailed advice to its staff on precautions to take if they were if in contact with
      bovine material. The Health and Safety Executive (HSE) warned farmers and
      hauliers about the risk of aggressive behaviour in any BSE-affected animals they
      were handling.



      Those at risk

      1032 However, these early warnings during the period up to December 1989
      reached only some of those handling risk material from cattle. Others were vets in
      private practice, waste tip and incinerator operatives, slaughtermen and butchers,
      knackermen, hunt kennel and maggot bait farm workers, renderers and animal feed
      handlers. Laboratory workers, teachers and students were handling cattle glands and
      tissues. Workers in zoological parks needed guidance. Later on, medical and
      healthcare professionals, mortuary workers and undertakers needed to take special
      precautions in respect of human victims of vCJD. There was also a wide spectrum
      of occupations handling bovine material being processed for food and other uses,
      such as fertiliser and collagen.

      1033 Ultimately the main occupations at risk were identified and advice given. But
      this was a long-drawn-out process. It took over three years to complete the task of
      issuing simple warnings and basic advice to the most obvious high-risk trades. A
      further two years passed before full guidance went out to those handling risk tissues
      in laboratories, hospitals and mortuaries.

      1034 The following, heavily condensed chronology of the events traced in
      Volume 6, Chapter 8 shows when advice was issued to the main at-risk groups. It
      illustrates how protracted the process was, even where it was agreed that a particular
      group of workers needed to be speedily alerted.

      Chronology of occupational safety advice

      May 1988                 HSE issues guidance for cattle handlers about aggressive
                               BSE cases.
      July 1988                MAFF issues guidance to its veterinary and laboratory
                               staff.
      November 1988            Further MAFF guidance to its staff handling tissues.
      February 1989            Southwood Report says HSE is considering appropriate
                               action.

198
                                                                      OCCUPATIONAL RISK


9 March 1989        MAFF asks HSE for meeting on guidance to farmers,
                    knackermen and workers at disposal sites.
29 March 1989       HSE identifies slaughterhouses as a possible risk.
April 1989          MAFF puts draft interim advice to HSE about carcass
                    handling.
9 June 1989         Meeting between HSE, MAFF and DH (first of series).
                    Brainstorming identifies farmers, vets, slaughterers,
                    knackers, butchers, stockmen, market handlers, fell
                    mongers, renderers, lab workers, those working at
                    incinerators, artifical inseminators, local authority
                    inspectors. MAFF considers the first four need urgent
                    advice.
25 July 1989        MAFF drafts advice to vets. British Veterinary Association
                    (BVA) agrees to draft own guidance.
8 August 1989       HSE issues news release on advice to carcass handlers
                    mooted in April.
11 September 1989   HSE undertakes to redraft MAFF draft guidance note to
                    abattoirs.
December 1989       HSE issues general information sheet on handling
                    zoonoses in agriculture. Passing mention of BSE says no
                    evidence that it is transmissible to humans.
January 1990        MAFF issues guidance agreed with BVA for veterinary
                    surgeons. HSE considers no immediate guidance for
                    farmers and farm workers is needed. MAFF disagrees.
February 1990       HSE publishes pocket carry cards on BSE and carcass
                    disposal.
March 1990          HSE publishes Guidance Note 5 on occupational risks of
                    BSE for workers in abattoirs and meat trade.
10 May 1990         When a TSE is diagnosed in a cat, Dr Pickles suggests
                    neurophysiologists and others might need advice.
31 May 1990         Agreement that guidance is needed for renderers. More
                    meat trade advice desirable on deep cuts, use of bandsaws
                    and inhalation of material.
June 1990           MAFF advisory note for farmers on handling BSE
                    suspects, and breeding.
24 August 1990      MAFF guidance to zoo workers.
6 September 1990    HSE/MAFF/DH decide against further advice for meat
                    trade, which is opposed to it as drafted, and to leave aside
                    for the time being guidance to renderers.
February 1991       Working Group of Advisory Committee on Dangerous
                    Pathogens (ACDP) set up to prepare health and safety
                    advice on handling human and animal TSEs.
15 March 1991       HSE/MAFF/DH decide guidance for renderers is needed.
7 October 1991      HSE/MAFF/DH identify dangers of cuts from splitting
                    cattle heads and spines. Agree guidance needed for
                    knackers, hunt kennels and maggot bait farms.
                                                                                   199
FINDINGS AND CONCLUSIONS


         October 1991             Draft fast-track letter for medical professionals circulated
                                  in ACDP Working Group (ACDPWG).
         28 November 1991         Food National Interest Group (NIG) advice note to HSE
                                  Inspectors about forthcoming comprehensive advice on
                                  precautions for knackers, renderers and
                                  slaughterhouses. Emphasis on employer surveillance,
                                  hygiene of pithing rods and risks of hand-scooping of
                                  brains.
         9 June 1992              HSE issues comprehensive advice for knackers,
                                  renderers and maggot bait farms.
         8 December 1992          Fast-track letter issued to medical professionals.
         September 1994           ACDPWG guidance on TSEs published.
         April 1995               Guidance issued in ‘Communicable Disease Report
                                  Review’ for all those handling human cadavers.
         December 1995            HSE/MAFF/DH working group meets for first time since
                                  October 1992. Agrees to reinforce present guidance.
         January 1996             Update of HSE’s Guidance Note 5 for slaughterhouse/
                                  meat trades issued.
         June 1996                ACDP guidance issued for all workers in contact with
                                  BSE.

         1035 As we built up this reconstruction of events from documents made available
         to us and witness statements, we were dismayed by the delays that occurred in
         advising workers at risk from contact with the BSE agent. Time was not available
         to explore this large field of evidence in depth at our oral hearings and with further
         witnesses. Our Report therefore does not attempt to pinpoint the actions of
         individuals but rather to look at weaknesses in the system that caused us concern.
         Two illustrative examples are described below.

         1036 The first was the issue of advice from the Advisory Committee on Dangerous
         Pathogens (ACDP) to laboratories, medical workers and undertakers. Fuller details
         are in vol. 6: Human Health, 1989–96, Chapter 8. The second was the issue of
         advice from the Department of Education and Science (as it then was) to schools
         about dissecting bovine eyeballs. Fuller details are in vol. 6: Human Health, 1989–
         96, Chapter 9. We conclude by drawing attention to some general points that struck
         us on the handling of occupational safety advice.



         ACDP advice to laboratories, medical workers and
         undertakers

         1037 The HSE had an established role on national guidance about handling
         dangerous pathogens. It also looked for expert outside advice to the ACDP, which
         reported jointly to it and DH. The ACDP Chairman was Dr Tyrrell.

         1038 The ACDP had been closely involved in the categorisation of levels of
         risk from pathogens and advising on appropriate precautions. It had reviewed
200      procedures for handling CJD and it was natural for the HSE and DH to look to it for
                                                                           OCCUPATIONAL RISK


advice on handling other TSEs. A Working Group of the ACDP (ACDPWG) was
set up in February 1991 to:

       . . . report to the ACDP on the need for additional guidance on health and
       safety aspects of work with animals or humans, their tissues or in vitro
       systems infected or potentially infected with spongiform encephalopathy
       agent, and to draw up guidance.

1039 Professor Peter Biggs was asked to chair the Working Group, but Dr Pickles
stood in for him at the first couple of meetings. Displaying the same energy and
purposefulness as on other matters, she launched the work with her own paper. This
not only provided draft outlines of the scope of the document that might be prepared
but suggested a handling plan and timetable to enable the guidance to appear at the
earliest possible date. Unfortunately, that timetable soon faltered and sank into a
drafting morass. The following chronology illustrates this. The 14-month history of
a so-called ‘fast-track’ professional letter for neurosurgeons is distinguished by
italics. The ‘Guidance Document’ had a gestation period of over three years.

Chronology of drafting of ACDPWG advice

4 December 1990         ACDP agrees to set up ACDPWG.
January 1991            Dr Pickles circulates draft paper.
28 March 1991           First meeting of ACDPWG discusses Dr Pickles’s paper.
13 May 1991             Second meeting adopts Dr Pickles’s paper for internal use
                        as the ‘Reference Document’. This is to be the basis for
                        briefer practical guidance for wider circulation – the
                        ‘Guidance Document’.
6 August 1991           Third meeting reviews second draft of Reference
                        Document.
                        First draft of Guidance Document.
October 1991            ACDPWG secretariat circulates draft ‘fast-track’
                        professional letter (PL) for neurosurgery and ophthalmic
                        staff.
24 October 1991         Fourth meeting discusses third draft of Reference
                        Document and agrees extensive redrafting needed for wider
                        circulation.
                        Guidance Document needs recasting.
                        Professional letter (PL) to be issued quickly. DH to take
                        forward.
30 October 1991         ACDP meeting told fourth draft of Reference Document is
                        ‘more or less the final draft’.
                        ACDPWG welcomes any comments on second draft of
                        Guidance Document ‘as soon as possible’.
28 November 1991        SEAC discusses draft Reference Document. Final draft
                        promised for new year.
December 1991           Secretariat circulates third draft of Guidance Document.
                                                                                       201
FINDINGS AND CONCLUSIONS


         14 January 1992         Fifth meeting: Reference Document to be available on
                                 request; Guidance Document to be widely distributed. Both
                                 need redrafting.
                                 First draft of PL considered.
         27 January 1992         Second draft of PL circulated.
         June 1992               Fourth draft of Guidance Document circulated.
         15 June 1992            Sixth meeting: no further work being done on Reference
                                 Document. Guidance Document has higher priority.
                                 Third draft of PL considered and amended.
         7 August 1992           Fourth draft of PL distributed.
         8 December 1992         Fifth and final draft of PL issued to neurosurgery and
                                 ophthalmic staff.
         15 February 1993        Fifth draft of Guidance Document circulated.
         February 1993           Sixth draft circulated.
         5 March 1993            Seventh meeting: members asked to consider all aspects of
                                 Guidance Document.
         24 May 1993             Eighth meeting: ACDP should aim to issue Guidance
                                 Document only. Final comments sought on Guidance
                                 Document.
         May 1993                Guidance Document agreed.
         14 June 1993            ACDP accepts Guidance Document.
         June 1993 to            Correspondence about publication details.
         September 1994
         24 September 1994       Publication of ‘Precautions for work with human and
                                 animal TSEs’ (The Guidance Document).

         1040 Witnesses suggested a variety of reasons for this sorry tale. They included
         uncertainty about appropriate decontamination procedures and about blood
         products; pressure of other work on the secretariat; and being side-tracked into
         protracted drafting time on the professional letter of warning on neuro- and
         ophthalmic surgery procedures. Once the Working Group had become caught up in
         a cycle of widely spaced meetings to consider substantial redrafting, they were
         constantly overtaken by emerging new information. Professor Biggs described it
         graphically:

                In a way, the Working Group was on a treadmill in the sense that any delay
                arising from the time needed to address a subject, or any other reason, was
                time during which new information became available requiring re-
                addressing subjects already dealt with.

         1041 A background factor influencing the handling of the exercise was the
         controversy over whether human TSEs were a category 2 risk or, as some argued,
         should be in category 3, requiring more rigorous safeguards. There was also debate
         over whether BSE should be categorised at all, it being open to question whether it
         was a human pathogen.

202
                                                                           OCCUPATIONAL RISK


1042 Further delays were then incurred until September 1994, after the document
had been agreed by the ACDP in mid-1993. We were told that this was while DH
finalised advice on at-risk patient groups inadvertently treated with CJD-infected
medicines or tissue grafts.

1043 While each of these reasons was no doubt thought to be valid justification at
the time for taking a measured pace, collectively they produced what seems to us
a quite unacceptable delay. The workers concerned were in occupations that
potentially exposed them to particularly high risks, yet they were among the last to
receive guidance. The best was allowed to become the enemy of the good.



The issue of guidance to schools about dissecting
bovine eyeballs

1044 We turn now to our other cautionary tale, this time involving a different part
of Whitehall, the Department of Education and Science (DES), as it was then
known. We deal with this topic at some length in vol. 6: Human Health, 1989–96,
Chapter 9. The dissection of bovine eyeballs in biology lessons was one of the
‘unusual pathways’ for possible disease transmission – to teachers and pupils – and
needed to be addressed, since the eye is closely associated with the brain structure.
There was no basic disagreement among officials about that. What went wrong was
that the relatively simple task of agreeing the text of a brief warning note about it
turned into a two-year saga.

Chronology of guidance on bovine eyeball dissection

27 September 1989       MAFF discusses the issue in context of the SBO ban.
                        Agreed effect would be minimal due to availability of
                        sheep and pigs’ eyes as alternatives for dissection.
                        However, MAFF suggests amending Regulations to
                        remove eyes before staining.
February 1990           Scottish Education Department consults and issues advice
                        against using bovine eyeballs in Scottish schools.
20 February 1990        Dr Pickles raises issue of theoretical risk with MAFF and
                        with Dr Diana Ernaelsteen, Medical Adviser to DES.
June 1990               SEAC advises that eyes of cattle more than 6 months old
                        should not be used for dissection in schools.
July 1990               Dr Pickles informs Dr Ernaelsteen of SEAC advice and
                        about the advice issued in Scotland. Dr Ernaelsteen to
                        discuss within DES whether there is a need for
                        promulgation of general advice within England.
July 1990               Welsh Office officials ask Dr Pickles whether guidance has
                        been issued following SEAC advice. Dr Pickles refers them
                        to Dr Ernaelsteen.
                        DES Schools Branch 3 accepts responsibility for issuing
                        guidance.
                                                                                        203
FINDINGS AND CONCLUSIONS


         28 August 1990      First draft of submission to the Minister recommending the
                             discontinuance of eyeball dissection.
         21 September 1990   DES is reluctant to ban all bovine eyeball dissection and
                             asks about ovine and pig eyeball dissection.
         4 October 1990      Dr Ernaelsteen says ovine dissection is unsuitable, but pig
                             or horse eyeball dissection and using bovine eyeballs from
                             calves under 6 months old is acceptable.
         5 October 1990      Mr Ron Jacobs (DES) undertakes to revise the first draft of
                             submission to Ministers.
         8 January 1991      DES prepares second draft submission to Ministers.
         25 February 1991    Dr Ernaelsteen expresses concern to DES at delay in
                             issuing advice.
         19 April 1991       HMI queries whether advice issued yet.
         25 April 1991       DES circulates revised draft of proposed advice to be
                             cleared with Ministers.
         9 May 1991          MAFF tells DES it is content with advice.
         February 1992       Mr Jacobs leaves post and passes third and final draft to
                             Mr M B Baker (DES).
         March/April 1992    DES seeks cross-departmental views on guidance.
                             MAFF queries why the procedure is taking so long but is
                             content with advice. DH is content with advice.
                             HSE doubts there are any problems but will contact DES
                             soon.
         16 April 1992       Mr J Creedy of HMI draws attention to articles in medical
                             journals which state that risk is minuscule.
         21 May 1992         Dr Ernaelsteen advises DES that guidance is not timely
                             now.
         June 1992           DES draft submission to the Minister stating it is wise not
                             to take advice further. This is sent to Mr Baker.
                             DH queries progress on advice.
         August 1992         Welsh Office queries progress on advice.
         7 September 1992    DH again queries progress on advice.
         30 September 1992   Mr Baker states he is not willing to give this high priority
                             due to Dr Ernaelsteen’s advice.
         14 October 1992     DH stresses that advice should be issued and that DES
                             should not reject SEAC advice.
         28 October 1992     DES responds stating that it will put submission to
                             Ministers.
         29 October 1992     DES sends a submission to the Minister of State on bovine
                             eyeball dissection.
         15–21 December      Guidance issued and sent to education establishments in
         1992                England.
         7 January 1993      Guidance issued and sent to educational establishments in
                             Wales.
204
                                                                           OCCUPATIONAL RISK


1045 We know this episode has rightly been investigated by DES itself. Mr Baker
had identified the issue as a matter for his branch, Schools Branch 3, in July 1990.
We have concluded that steps should have been taken to avoid the delay that
occurred from May 1991 to December 1992. As he himself acknowledged,
responsibility for this delay fell in considerable measure to Mr Baker. Mr Jacobs,
who had day-to-day responsibility for the issue within Mr Baker’s branch until
February 1992, also shared some of the responsibility. Mr Baker and, to a lesser
degree, Mr Jacobs should have ensured that this matter was promptly and properly
addressed. Mr Baker and Mr Jacobs faced a heavy workload of competing priorities
at that time and this is something we have borne in mind.

1046 Unfortunately, it seemed to us that some delay was also caused by
Dr Ernaelsteen’s advice in May 1992 that guidance was no longer timely. Having
commendably stood her ground up to then, we consider it regrettable that, in the
absence of any new medical facts, Dr Ernaelsteen countenanced any further delay
in issuing advice on stopping the practice of bovine eyeball dissection.

1047 The story seemed to us to offer salutary lessons. The people handling the
matter were far from the scene of action on BSE. That was other Departments’
business. Their own Minister was not involved. No framework of overall action was
in place through which they were accountable. All in all there seemed to be no
hurry. Meanwhile other work was more pressing. Safety of pupils and teachers was
outside DES’s normal remit and many people had to be consulted. As with all civil
service documents, there was an urge to refine and polish wording. As time went
by, the delay itself made the issue of guidance less appealing.

1048 Here as in other areas, excessively reassuring language about the risk from
BSE sedated those who needed to act. Insofar as they had a perception of the
situation, it was that the risk was remote. There was no strong sense of ‘ownership’
of the topic to overcome the difficulty of working across normal boundaries in
unfamiliar territory. There was no overall frame of reference and accountability.



Overview of occupational health

1049 The factor that most influenced the pace of action in both these case studies,
and in reviewing occupational safety generally, was the belief that the risk from
BSE was remote. We discuss elsewhere the reverberations of the wording used in
the Southwood Report. In particular, the recommendation to the HSE in the Report
about the issue of further advice to at-risk groups was scarcely a clarion call to
action. The HSE attributed MAFF’s eagerness to get advice issued to political and
media pressures. It saw no reason to depart from its normal number-based risk
assessment approach and measured processes for evolving guidance. These were
sound but slow.

1050 A second factor was the absence of a comprehensive review of pathways of
transmission to ensure that all the critical points had been identified. As discussed
in Chapter 9 of Volume 7, Dr Matthews of MAFF, immediately after his meeting
with the HSE on 9 June 1989 to discuss the issue of advice, had commissioned a list
of slaughterhouse products and their destinations. This was intended to assist
thinking about high-risk occupations that should be given early consideration.          205
FINDINGS AND CONCLUSIONS


         Unfortunately, this exercise was not taken much further. Had the audit of possible
         pathways of infection proceeded, it might have helped to pinpoint where the issue
         of urgent advice could not wait.

         1051 The third factor was the inherently slow metabolism of the consultative and
         drafting arrangements on occupational safety. While polished and carefully agreed
         detailed guidance was to be desired, it ought not to have been at the expense of
         prompt and straightforward interim warnings.




206
9. Potential pathways of
infection

Consideration of an audit of the uses of cattle tissues

1052 The last part of vol. 7: Medicines and Cosmetics deals with a topic that
concerned not just medicines and cosmetics, but also many other industries and
activities where BSE posed a threat. This was the need to establish all the ways in
which cattle tissues were used, in order to ensure that BSE infection was not spread
by unrecognised routes.

1053 We consider it was a top priority to prepare an overview of this kind. A
proper understanding of all the ways in which cattle tissues were used was
fundamental to the planning of suitable measures to stop the disease from spreading.
Those responsible for action in each area of concern needed to be contacted and the
risk assessed. The industries and groups of workers involved stretched far beyond
the ambit of MAFF. Coordination of measures and ensuring they covered all the
ground was going to be important. Various pieces of safety legislation might have
to be deployed. Many Departments and public bodies would be involved in
enforcing and monitoring individual activities. Once action had been taken, the map
of identified pathways could be used to monitor the situation, and ensure new
information was relayed to those who needed to know it.

1054 However, a comprehensive overview exercise was not carried out. Gaps in
knowledge were still causing problems seven years after the need for an overview
was identified. This led to new proposals within MAFF for a research study. The
term ‘audit trail’ was applied to it, a convenient description we have used here.

1055 What follows is a condensed account of what happened. The fuller story and
analysis can be found in vol. 7: Medicines and Cosmetics, Chapter 9.

The Tyrrell recommendation

1056 The Southwood Working Party in 1988 had agreed with Dr Pickles that it
would be useful to have an epidemiological flowchart to determine what bovine
material was used for. They followed up the most pressing issues they had
identified, but did not themselves prepare an overview of all uses.

1057 The matter was picked up in the Tyrrell Report on research into TSEs a year
later, in June 1989. This had an item as follows:

       Item A1d More detailed investigation into the fate of bovine (and ovine)
       tissues and products that could lead to infection being spread by as-yet-
       unrecognised routes.

                                                                                       207
FINDINGS AND CONCLUSIONS


                Some uncertainty remains as to whether all the possible routes of
                transmission from bovine (and ovine) tissues to other species have been
                considered and appropriate action taken. Small scale users of bovine
                products, such as the cosmetic industry, may not be covered by the present
                regulations and guidelines. There are no formal proposals for work of this
                sort and consideration should be given as to whether such a study should be
                commissioned *** [ie, three-star, top priority]

         1058 Along with the other three-starred items, A1d was approved by Ministers for
         immediate action. MAFF had divided all the recommended projects into two tables.
         Table 1 contained items to be wholly funded by MAFF; Table 2 listed the
         remainder, to be jointly funded or to fall entirely to others. The audit and cosmetics
         item, captioned ‘Spread of infection by unrecognised routes’, was listed in Table 2.
         The wording was vague: ‘Those routes currently considered important are being
         pursued. Scientific progress may reveal the need for further action. This issue is of
         importance also to DH.’

         1059 There had meanwhile been a meeting with the HSE in June to follow up the
         Southwood recommendation on occupational risk. This was attended by
         Dr Matthews, a veterinarian in MAFF. After the meeting he asked Mr Hutchins, a
         Senior Veterinary Officer in MAFF’s Meat Hygiene Veterinary Section, for a
         background paper listing the destinations of slaughterhouse products. The object
         was to help identify workers at risk. Mr Hutchins promptly produced a businesslike
         list of raw by-products, processed by-products and their use. MAFF officials were
         at this stage heavily engaged in deciding which tissues needed to be covered by the
         proposed SBO ban. They did not seek to trace any further the fate of the items
         identified in the list or to contact other Departments that might have an interest in
         them.

         1060 In March 1990 Mr Lawrence of MAFF’s Animal Health Division drew up a
         progress chart of where each of the Tyrrell proposals now stood. This revealed that
         nothing had been done about the audit since Ministers had agreed it the previous
         August. Cosmetics, as we have seen, were being tackled, thanks to Mr Roscoe at
         DTI.

         1061 Faced with this awkward situation, Mr Lawrence turned to the MAFF Meat
         Trade Adviser, Mr Chris Rogers, for advice about outlets for slaughterhouse
         material. Mr Lawrence appears to have been unaware of the list prepared by
         Mr Hutchins. Mr Rogers identified many of the same items, adding his own
         observations. One of these concerned a different sort of by-product, namely
         slaughtering and rendering waste. We return to that later in this chapter.

         1062 In May, while being briefed for a Parliamentary Debate on BSE, the MAFF
         Minister, Mr Gummer, learned that the audit had not yet been set in hand. He
         instructed that it should go ahead forthwith and that MAFF should fund it. Some
         confusion and misunderstandings then ensued about whose job it was to draft the
         protocol for the work. The details appear in Volume 7.

         1063 The upshot was several more months of inaction. SEAC was told on 2 July
         1990 that the project had not been followed up, but that MAFF was seeking
         information from slaughterers about where bovine tissues went so as to provide the
208      basis for a comprehensive picture of the products in which they might be used. It
                                                              POTENTIAL PATHWAYS OF INFECTION


appears that MAFF officials were taking a narrow view of what was required. A few
days later, Mr Lowson told Dr Kenneth MacOwan, who managed the MAFF
research budget, that MAFF had kicked this off through an enquiry at
slaughterhouses to establish what happened to the whole range of bovine tissues,
and that pending the results of this enquiry he would not see a need to direct
resources to the item.

1064 Thereafter matters gathered dust until March 1991, when SEAC called for
a paper on non-food uses of bovine materials and MAFF set about updating its
progress chart. Dr Pickles queried the assertion in the MAFF chart that DTI, MAFF
and industry had the item in hand. The dust was blown away with a vengeance. It
was now revealed that nothing had been done. Mr Maslin told Dr Pickles:

       From our papers it would seem that there has been no ‘study’ initiated. The
       references to ‘DTI, MAFF, Industry’ was I assume included in the summary
       chart in the early days and has simply been perpetuated in later charts. Alan
       Lawrence recalls that this was a matter raised with Mr Gummer before the
       BSE Parliamentary debate last year. It seems however that this area has
       fallen through the cracks.

1065 The chart had confused the follow-up on cosmetics – where DTI had been in
touch with the industry – with the wider audit.

1066 By way of response to the situation, Mr Bradley of the CVL provided an ‘off
the top of my head’ set of suggestions about non-food uses. Mr Maslin suggested to
Dr Pickles that these and Mr Rogers’s list of the previous year might be
amalgamated to form the paper sought by SEAC. There ensued a spirited exchange
between MAFF and DH about who was to blame for the item falling through the
cracks.

1067 In a minute to Dr Pickles, Mr Lowson conceded this ought not to have
happened:

       I entirely agree that it is not satisfactory that this item on the Tyrrell shopping
       list should not have received the attention it deserved.

1068 However, he did not accept that the blame lay with MAFF. He had
understood Dr Pickles was drafting the protocol, though:

       . . . it was a hot afternoon, a long meeting and nobody produced a note so I
       would not want to be too critical of the fact that nothing seems to have
       happened as a result. No doubt for our part we should have been more
       assiduous in trying to find out what was going on.

1069 In response to Mr Maslin’s suggestion about the list, Dr Pickles observed:

       Of course I could make a start at a ‘list’ but the purpose of a research study
       was to investigate more formally as to what actually happens, not what some
       of us think might happen.

1070 We entirely agree with Dr Pickles’s observation. What was needed was a full
and accurate picture tracing products through their various handling and processing          209
FINDINGS AND CONCLUSIONS


         stages. This was going to extend well beyond the boundaries of MAFF’s
         knowledge.

         1071 What in fact happened was that, with a few additions, Mr Hutchins’s original
         list of uses from June 1989 was annexed to a paper by Dr Pickles for the SEAC
         meeting on 28 June 1991. SEAC was asked to consider if the list was complete and
         if these uses presented any risks to the public or to workers. SEAC thought that in
         general no problems arose but was still concerned about some matters. One of these
         was the risk that unstained and unsterilised SBO might end up in products that could
         come into contact with humans.

         1072 Mr Lawrence prepared a paper reviewing the controls and the guidance on
         pharmaceuticals. It took an optimistic view that these covered the situation but
         suggested that a further check could be made through the abattoir owners on the
         destination of by-products. This suggestion does not appear to have been discussed
         by SEAC when the paper was tabled in September, nor does it appear to have been
         followed up. The SEAC interim report on research published in April 1992 said that
         the fate of bovine tissues had been examined in-house by MAFF and was not
         progressing as a formally commissioned piece of work.

         1073 Thereafter the need for an audit of this kind did not resurface until 1995,
         when it emerged in the context of a review of MAFF-funded TSE research. The
         proposed audit was slow in getting off the ground. In February 1996 SEAC advised
         that it was high priority to carry out the audit and that sheep tissues should be
         included in the study. The work was commissioned from outside consultants in June
         1996 and completed in May 1997.

         Reasons for this outcome

         1074 Why did the matter turn out this way? Various factors were at work. MAFF
         thought that what was required could be done in-house by existing staff. No
         association appears to have been recognised between the risk for workers in
         identified industries and the risks that might be continuing to be carried in the
         material itself. There had been some confusion from the start about the status of the
         study which the Tyrrell Report had identified. Was it truly research or simply a fact-
         finding exercise? The indeterminate wording of the initial allocation in Table 2
         provided no impetus to anyone to move matters forward. Subsequently the
         compressed reporting in the progress chart of the coupled cosmetics and audit
         proposals gave a misleading impression about whether action was in hand and who
         was in the lead.

         1075 However, given the importance of doing the work, all these difficulties could
         undoubtedly have been overcome had the project had a champion. None emerged
         to press for the work to be done and secure action. This lack of ownership of the
         project spelt its doom.

         Where responsibility lay

         1076 We have no doubt that whether or not the Tyrrell Report had listed it as an
         item, an exercise of this sort was a necessary precursor to an effective government
210
                                                           POTENTIAL PATHWAYS OF INFECTION


response to BSE. Within MAFF, Animal Health Division, headed by Mr Lowson,
was responsible for developing policy on BSE. The role of working up policy
proposals and submissions for Ministers, and setting up the arrangements to carry
them out, was generally a Head of Division responsibility. It seems to us that
Mr Lowson had a responsibility to ensure as far as possible that the development of
policy on BSE was properly informed by data from appropriate scientific research
and field studies.

1077 The work done by Mr Hutchins and Mr Rogers to compile lists of uses was
a good start but no more than that. They did not seek to trace through what happened
to the products and what risks might be associated with them. Yet these lists appear
to constitute the sum total of the ‘in-house work’ that SEAC was assured made a
full audit premature for the time being. This was scarcely a systematic investigation,
nor was it of value without policy action to follow up the clues it offered.

1078 We consider that the need for the work on an overview to be done should
have been obvious at the time. Mr Lowson agreed that he needed no special advice
from scientists about whether or how to carry out a fact-finding exercise to map all
the ways in which cattle products might be used. New though he was in his post, in
our view he should have ensured that this matter was promptly and properly
addressed.

1079 We considered whether Dr Pickles shared responsibility for this. On
reviewing her actions, it seems to us that at each stage she pushed hard for the audit
to be carried out. She took independent action in an effort to secure DH funds to
break the financing deadlock; and she drew the failure to carry out the project to
Mr Gummer’s attention, which led directly to his instruction that the work should
go ahead. Thereafter she made efforts to get the protocol drafting under way at
MAFF. We do not think she could have done more than she did.

1080 We have been at pains to explore what happened to the audit. We see the
failure to carry it out as a serious shortcoming in the response to the emergence of
BSE. Time and again the story we have explored has shown that in the main the
right action was taken, but often more belatedly than it could have been. Some
matters, such as the safety of gelatine and tallow which were used for a wide range
of different purposes, were dealt with only late in the day. Others, such as waste
disposal from slaughterhouses and rendering plants dealing with SBO, were barely
identified at all. Where work was put in hand there were often no deadlines. Urgent
warnings were delayed while drafts were refined. Some of this could have been
avoided if all had been working within a recognised overview and timetable as a
framework for tackling matters, under a firm guiding hand.




                                                                                         211
      10. Pollution and waste control
      1081 When slaughter and compensation measures were introduced, the carcasses
      of the cattle in question became the property of MAFF. The Ministry had already
      established disposal procedures to apply to the handling of BSE carcasses.
      Instructions were swiftly distributed to field staff. The preferred option was
      incineration at MAFF premises followed, ‘in order of decreasing desirability’, by
      off-farm burning on waste ground or at a local authority site, incineration on farm,
      burial at a local authority tip, and burial on farm by a contractor.

      1082 The problem that arose with the BSE cases was their sheer volume. As
      numbers rocketed in 1989 and 1990, constantly outstripping forecasts, MAFF was
      forced to adopt various expedients while new incinerator capacity was being sought.
      This was not a simple undertaking. There was local hostility both to the emergency
      measures of open burning and tipping that had to be adopted and to the issue of
      planning permissions and other licences for new incinerator capacity. As fast as new
      provision was made, the number of reported BSE cases grew yet greater. Only in
      1992, a year in which 43,449 carcasses had to be destroyed, did MAFF get the
      disposal situation fully under control. Thereafter carcasses were no longer buried
      and virtually all incineration was at designated premises.

      1083 Volume 6: Human Health, 1989–96, Chapter 10 describes the steps that
      MAFF took and the difficulties it encountered. Ministers took a close interest in
      what was happening, both because they wished to be assured that the policies
      adopted were not creating health risks, and because of the continuing public
      sensitivity about some of the measures adopted. The potential impact on
      overstrained waste disposal facilities was not unnaturally a consideration in some
      of the policy issues that arose. By their nature carcasses had to be disposed of
      promptly if they were not to constitute a threat to public health. Moreover this was
      far from cost-free.

      1084 Overall MAFF handled this difficult and unpopular task of carcass disposal
      both energetically and competently.

      1085 In the process, however, they had to deal with various objections from those
      with responsibilities for environmental protection. There was growing public
      concern about the nature and persistence of the BSE agent in waste whether burnt,
      used as landfill or discharged as effluent. We shall return to this point. But first we
      review what happened with a different sort of waste, the Specified Bovine Offal.

      1086 Here matters were not so straightforward. Responsibility for disposal did
      not rest with MAFF but with the owner of the material. Initially there was no
      requirement to distinguish SBO from other meat unfit for human consumption.
      Most of this unfit meat was not regarded as waste but rendered to produce MBM
      and tallow. As one renderer put it, ‘We were very much a by-product industry. We
      cleared up the mess from the slaughtering industry trades.’ In 1991, after the
      introduction of the animal SBO ban and SEAC’s advice that the protein product of
      SBO should not be used as fertiliser, MBM could only be disposed of at a licensed
      destination. It had become controlled waste.
212
                                                                POLLUTION AND WASTE CONTROL


1087 The disposal of some other sorts of BSE waste was given much less attention
than SBO. These were the side products of slaughtering cattle, and destroying,
treating or processing cattle material.

1088 They took various forms. Effluent passed down drains to sewers and rivers.
Blood, slaughterhouse or rendering plant waste, including that from plants that
rendered SBO, and sewage sludge from works handling their effluents might
lawfully be spread as fertilisers on land where animals subsequently grazed or crops
were grown.

1089 While emissions from plants required formal consents from water authorities
and others, in practice none of the usual precautions or conditions which applied to
discharges would have inactivated the BSE agent. It appears to have been assumed
that it was sufficiently diluted to pose no risk. This was a matter that was not
thoroughly investigated until work was commissioned by the Environment Agency
in 1996 to trace all the environmental pathways along which BSE material might
travel, and to assess the degree of risk and appropriate precautions for each.

1090 Although much of the evidence offered to us about the BSE risk from effluent
from the Thruxted Mill rendering plant in Kent related to a time outside the period
covered by this Inquiry, the concerns expressed and the action taken in response to
them illustrated some of the difficulties posed by BSE for those responsible for
dealing with secondary wastes.

1091 The environmental regulation regime had been found wanting in many
respects towards the end of the 1980s. Discussing the disposal of solid waste the
Select Committee on the Environment observed in 1989:

       Never, in any of our enquiries into environmental problems, have we
       encountered such consistent and universal criticism of existing legislation
       and of central and local government as we have during the course of this
       enquiry.

1092 The system was at the same time having to be adapted to meet EU
requirements designed to ensure that waste was recovered or disposed of without
endangering human health or harming the environment. The principle of ‘producer
pays’ for disposal costs was being introduced. Major reorganisation of
responsibilities was undertaken and new powers brought in under the Environment
Act 1990.

1093 Thus the task of disposing safely of BSE carcasses and SBO took place
within a regulatory system that was in trouble and in transition. Chapter 8 in vol. 14:
Responsibilities for Human and Animal Health describes the main features of the
system and the major changes introduced to rearrange responsibilities and to
regulate waste and sewerage, waste tips, waste spreading and air quality.

1094 These were wide-ranging matters. We could not attempt to add detailed
exploration of them to the many other topics our Inquiry has had to cover. It is clear,
however, that as a potential transmission pathway for BSE, general waste disposal
systems received scant attention prior to 1996. This matter was not specifically
referred to or addressed by the Southwood Working Party, the Tyrrell Committee
or SEAC. Yet all of them advocated a systematic review of the destination of all          213
FINDINGS AND CONCLUSIONS


         bovine materials. Had this been carried out as discussed in the earlier section of this
         chapter, it might have been expected to identify many of the matters touched on
         above, and to indicate where more research or development of new techniques
         would be valuable.




214
11. Wales, Scotland and
Northern Ireland
1095 BSE was a UK-wide threat needing a UK-wide response. That was speedily
and sensibly agreed by all concerned once it was apparent that BSE extended
throughout the United Kingdom. By common consent, MAFF and DH took the lead
role. In order to simplify our exposition of a highly complex and extended series of
events we have in our Report mainly concentrated on the actions of MAFF and DH
in England and the legislative measures that they introduced. These applied to or
were copied by the other three parts of the United Kingdom. We in turn have copied
the terminology that they often used in describing themselves collectively as the
Territories.

1096 In vol. 9: Wales, Scotland and Northern Ireland, we have been concerned to
see how the links between central government in London and government in the
Territories functioned in relation to BSE. We have been particularly interested in
identifying the extent to which the Territories sought to play an independent role or
to make an independent contribution in relation to the handling of the disease. In
this chapter we shall set out a summary of our main findings about the role of the
Territories.

1097 We found no fundamental differences in the nature of the response to BSE
throughout the UK. Like their colleagues in Whitehall, Ministers and officials in the
Territorial Departments worked closely together. Decisions were taken on the basis
of submissions and discussions. Where there were minor or temporary variations
from the general UK line in their actions, these did not in our view bear on the
course of the disease or expose animals and humans to a significantly greater or
lesser degree of risk.

1098 It was plain from all the evidence that the Territorial Departments were
strongly influenced at first by the MAFF perception of BSE as purely an animal
disease. They then found this perception confirmed by the Southwood Report. The
risk to humans was remote. The Report gave ‘quite a comforting message’. It is
difficult not to infer that this perception, coupled with the Government’s drive
towards ‘lifting the burden’ of regulation from industry must, as elsewhere, have
tempered enforcement zeal.

1099 Nonetheless, officials pressed ahead diligently with the agreed precautions.

1100 Inevitably with a canvas covering ten years, and a vast complex of
administrative actions, there were things that could with advantage have been done
a little differently and perhaps a little better. However, we were not looking for
perfection. We were interested in the light thrown by some of the failings we noted
on the way collective government works among Departments with different
geographical responsibilities, rather than different functional ones.

1101 We note first some features of what happened in Wales, Scotland and
Northern Ireland, and then set out some more general findings.                          215
FINDINGS AND CONCLUSIONS


         Wales

         1102 Welsh legislation and administrative arrangements closely resembled those
         of England. This simplified the task of coordinating action. We were struck by the
         quality of independent thinking that the Welsh Office medical team led by the CMO
         for Wales, Dr Deirdre Hine, applied to the issues raised by BSE. The team’s attitude
         reflected its effective combination of medical and epidemiological skills with first-
         hand knowledge of the realities of slaughterhouse operation. A similar working
         combination of skills at national level in Whitehall Departments could well have
         been fruitful.

         1103 There were no special features of the Welsh situation that dictated a different
         approach. However, the Welsh Office team had valuable insights to offer for
         national policy development and did their best to register them. Dr Hine wished to
         get closer to the thinking of SEAC. We applaud the alternative strategy she adopted
         towards its chairman, Dr Tyrrell, of successfully inviting him to Cardiff. Her
         interest in exploring the issues was natural in the context of her responsibilities to
         the people of Wales. It seemed to us that the various information blockages that she
         and her colleages encountered could have been overcome had there been a wish in
         Whitehall to involve the Territorial Departments more closely in the policy-making
         process.



         Scotland

         1104 Here there was not the same happy combination of skills and knowledge in
         place to bring together the animal and human health implications of BSE. Matters
         were very much left in the hands of the Agriculture Department. However, in 1990
         Dr Gerald Forbes, a former member of the Scottish Home and Health Department,
         expressed concerns about the risk that BSE posed to humans, which appear initially
         to have sounded a cautionary note with the CMO, Dr Kenneth Calman, and with
         Mr Graham Hart, who headed the Health Department. Dr Robert Kendell on the
         other hand, who took over as CMO in 1991, did not seek Dr Forbes’s views,
         regarding the Environmental Health (Scotland) Unit which Dr Forbes now headed
         as a ‘one man band’. Dr Kendell looked mainly to Mr James Scudamore, the
         Assistant Chief Veterinary Officer, Scotland, for advice about BSE. Mr Scudamore
         seems to have fulfilled his role admirably, both towards the CMO and in working
         closely with the Animal Health branch in the Department of Agriculture and
         Fisheries for Scotland (DAFS). However, as he told us, he had expected that his
         contributions from the veterinary and general MAFF perspective would have
         formed no more than one element in any Scottish Office assessment of an issue. We
         agree. But no such wider assessment appears to have been made by DAFS officials
         in relation to BSE.

         1105 We thought that this shortcoming could be attributed to weak links and lack
         of shared perceptions in the Scottish Office between those responsible for animal
         and human health. Dr Kendell told us that he simply assumed that it was his job to
         keep careful tabs on the human disease, and it was the job of DAFS to ensure that
         everything was right and proper on farms and in abattoirs. We saw little sign of joint
         working on BSE between the administrators in the Health and Agriculture
216      Departments. One manifestation of this was the pigeonholing of the hard-won
                                                  WALES, SCOTLAND AND NORTHERN IRELAND


SEAC papers by DAFS administrators as scientific, technical and ‘all Greek’. These
were never discussed and assessed jointly with Health officials, or indeed at all, nor
brought to the attention of the CMO, who later thought they would have been
‘enormously helpful’.

1106 It seems to us that those dealing with animal and human health could
profitably have shared knowledge about and discussed slaughterhouse practices, the
food chain implications if enforcement of Regulations was inadequate, and any
impact that this might have on handling BSE in Scotland. We also think that it was
desirable that a working competence in understanding the papers of a key advisory
committee such as SEAC should have been available in the Scottish Office.

1107 Happily the poor liaison did not create delays in the action taken by DAFS
to introduce Scottish legislation and apply the various precautionary measures
agreed on BSE. We have no criticisms of this. The House of Commons Agriculture
Committee had, in 1990, censured the delay in introducing the Scottish human SBO
ban to mirror the England and Wales Regulations of November 1989. However,
given the last-minute addition of sausage casings, which had a bearing on haggis
manufacture, and the troubles that immediately arose over the lawfulness and
adequacy of the 1989 SBO Regulations, we thought it not unreasonable that those
producing the Scottish equivalent should take the time necessary to avoid these
pitfalls.

1108 That said, the border between Scotland and England, and indeed between
England and Wales, is meaningless so far as the movement of people, animals and
goods is concerned. In these circumstances, human and animal health threats need
a common approach. As a general principle, it seems to us highly desirable that
when animal and human health safeguards are urgently needed, there should be
available powers to bring those into effect simultaneously across the whole of
Great Britain.



Northern Ireland

1109 Here there was indeed a significant physical border. Besides differing more
markedly in terms of its legislation and administrative arrangements, Northern
Ireland was separated from Great Britain by a wide sea crossing. It was reasonable
that Ministers and officials there should have given careful thought to whether to
follow the policy lead from London on making BSE a notifiable disease, and on the
ruminant feed ban. They decided not to do so at first.

1110 We did not think the delay in formalising notification made any difference.
However, we were concerned about the decision not to take immediate action on a
feed ban. Recycled infective material might already have been in local MBM, and
cattle eating it might already have become infected, thus prolonging any epidemic
in Northern Ireland. We noted that the decision to delay the ban was taken only after
outside consultation and analysis of various options. It was put to us that it was
justified by the absence of BSE outside Great Britain and by the beliefs held at the
time about the cause and distributing mechanism of the disease. Moreover, import
controls were put in place for MBM and live cattle. We concluded that the decision
was not unreasonable at the time, though with hindsight it would have been               217
FINDINGS AND CONCLUSIONS


         preferable not to delay. However, immediate precautionary introduction of a
         ruminant feed ban would probably have reduced the cases of BSE in the Province
         by only a small number. Northern Ireland was in any case far less affected by BSE
         that the rest of the UK.

         1111 After the first case in Northern Ireland was confirmed in November 1988, the
         NI administration closely followed the UK line on all matters, despite a hankering
         for independent health status for its cattle, with a view to restoring beef exports. We
         think they were right to keep in step with the rest of the UK.

         1112 We heard differing accounts of the usefulness of the NI cattle-tracking
         system in alleviating the effects of the BSE crisis in the Province. It does not appear
         to have been a significant factor during the period with which we were concerned,
         although it may have helped since in allowing the earlier resumption of exports than
         in the rest of the UK.



         Collective government and working relationships

         1113 Tackling BSE entailed a huge exercise in public administration. It required
         close working between Ministers and officials, consultation and cooperation
         between Departments and efficient follow-up action. Our Inquiry has been a review
         of all these matters and of how far collective government rose to the challenge.

         1114 Collective government across the different parts of the UK required its own
         set of working relationships. By and large the machine worked reasonably well, but
         there were many recognised endemic difficulties. Unsurprisingly these sometimes
         gave decision-making on BSE a bumpy ride. We were told with some vigour of
         frustrations about failures and delays in communication between Whitehall and the
         Territories.

         1115 In some respects this mirrored communication failings between Whitehall
         Departments, and between the cadres of administrative and professional advisers.
         For the Territories, travelling times to and from London exacerbated the problems.
         Typical examples of these difficulties, where BSE was concerned, included MAFF
         delays in telling Scottish administrators about the disease, DH disinterest in views
         from Scotland and Wales, and the absence of territorial officials from formative
         meetings.

         1116 Communication problems were particularly significant in relation to the
         Territories’ reliance on Whitehall for scientific expertise and risk analysis. It made
         sense that such work was not duplicated. But if the material passed on was meagre
         and late, consultation was purely token. Moreover, without access to the basic
         information, the Territorial Departments had to rely on the judgements already
         made in Whitehall and on Q&A briefing that might itself slide over the underlying
         issues. The handling of BSE cast some of these difficulties into strong relief. The
         lessons they offer for the future are described in Chapter 14.



218
12. Science and research
1117 Although only one member of our Committee is a scientist, our terms of
reference have required us to review, at second hand, a substantial body of scientific
learning and research. We are required to establish the history of the emergence of
BSE. In order to attempt to answer the questions of where BSE came from and why
it emerged in this country we have had to consider, among other things:

   •   epidemiological research;
   •   evidence on the technical aspects of rendering and the inactivating effect of
       rendering processes on TSE agents;
   •   transmission properties of BSE compared with those of scrapie; and
   •   strain-typing of the BSE agent after transmission to mice.

1118 More fundamentally, we have had to consider the complex research on the
very nature of TSEs. This is critical to the theory, now widely accepted, that BSE
has been transmitted as a result of recycling bovine protein that included infective
prion protein.

1119 In the course of our Inquiry we have received evidence from scientists who
espouse alternative theories, for example:

   •   the organophosphate theory; and
   •   the autoimmune theory.
We have had to consider whether these were viable alternatives to the
prion protein theory.

1120 More generally, our requirement to review the adequacy of the response to
BSE, taking into account ‘the state of knowledge at the time’, has required us to
follow the development of scientific knowledge about BSE between 1986 and 1996,
paying particular attention to those aspects which had a bearing on the likelihood
that BSE might be transmissible to man.

1121 We are also required to establish the history of the emergence of vCJD.
This has required us to consider the scientific research, both before and after
20 March 1996, which has focused on the question of whether the link between BSE
and vCJD is clearly established.



Scientific conclusions about BSE

1122 Our analysis of the scientific knowledge occupies the major part of
vol. 2: Science. We shall not attempt a summary in this volume. We shall simply set
out the conclusions that we have drawn from the scientific response to BSE:

                                                                                         219
FINDINGS AND CONCLUSIONS


               i.    The vector responsible for the epidemic of BSE in cattle was MBM

               The spread of BSE in cattle to the point where it became an epidemic came
               about from the use of meat and bone meal (MBM) in cattle feed. The MBM
               in question was infective because it had been made by rendering infective
               offal from cattle suffering from, or merely incubating, the disease. As little
               as 1 gram (or less) of this material could cause death if ingested by other
               cattle. It was so infective that accidental contamination of cattle feed with
               pig or poultry feed containing MBM was a significant factor in continuing
               to spread BSE after the ban on the use of MBM in cattle feed. Apart from
               MBM in feed, transmission from mother to calf is likely to have played a
               part. We cannot yet say whether contamination of pastures played a part. The
               suggestion has been made that the BSE agent may have been spread in the
               early stages in hormones used in veterinary preparations. This possibility
               cannot be discounted. But the overwhelming vector of the epidemic was
               MBM in cattle feed.

               ii.   The unmodified scrapie agents were not the agents responsible
                     for BSE

               While it was reasonable in February 1989 to accept the hypothesis that the
               cases of BSE being reported had come about through the rendering of
               carcasses of sheep infected with extant strains of scrapie established in the
               national flock, this theory is no longer plausible. We think it likely that the
               passive surveillance system failed to detect several earlier cycles of BSE in
               the South West of England in the 1970s and early 1980s. Each cycle was
               followed by more extensive contamination of MBM. Much of the recycling
               could not be detected because tissues from animals incubating the disease
               but not showing signs were involved; but it is likely that there were isolated
               animals which did develop signs and were slaughtered or died of the disease.
               BSE was unknown at the time and it seems possible that the disease in such
               cattle might have been ascribed to known disorders such as
               hypomagnesaemia or simply not explored. These early cycles began because
               a novel TSE agent originated in the early 1970s. The cause of this novel
               agent is likely to have been a new prion mutation in cattle, or possibly sheep.
               Moreover, other mammalian species whose carcass waste was included in
               MBM cannot be excluded. It is conceivable that the conversion of normal
               prion protein into its infective form was initiated not by a gene mutation, but
               by an environmental agent, such as a toxic chemical; this has not yet been
               achieved experimentally. Current knowledge suggests that the original agent
               was not the unmodified scrapie agent or agents. We have also noted a
               number of pointers which could have led to the conclusion by mid-1990, and
               certainly well before 20 March 1996, that the agent fuelling the BSE
               epidemic was not then (if it ever had been) the unmodified scrapie agent or
               agents. It is now not possible to be sure which of the hypotheses as to the
               origin of the novel agent is correct.

               iii. Changes in rendering

               It is a common misconception that reduction in temperature or a failure to
               prescribe minimum holding times in the rendering of carcass waste led to
220            failure of inactivation of the scrapie agent and transmission across the
                                                                 SCIENCE AND RESEARCH


species barrier to cattle. Changes in the rendering process in the late 1970s
and early 1980s, namely the switch from batch to continuous processing and
the abandonment of solvent extraction of tallow, might have led to reduction
in inactivation of the agent in MBM, but it is now known that the processes
used previously were also incapable of completely inactivating TSE agents.
No commercial rendering procedure has been designed capable of
completely inactivating BSE in MBM before or since.

iv. Confirmation of the central role of prion protein

All evidence points to the specific association of an abnormal form of the
prion protein and TSEs. In its normal shape, the prion protein (PrPC) does not
cause harm. In its abnormal shape (signified by PrPSc – a generic term for the
agents causing TSEs), it is resistant to the normal cellular processes of
degradation. Contact between normally shaped and abnormally shaped
proteins induces the normal to convert to the abnormal. This leads to a build-
up of the abnormal form of the protein, which accumulates in, and eventually
causes the death of, nerve cells. Nerve cells are particularly susceptible to
PrPSc because they cannot regenerate. The presence of PrPSc can be
demonstrated in the brain and spinal cord of all humans and animals affected
with TSEs. Incubation times in experimental animals correlate with the
infective dose of the agent, and these times are increased by treatment with
agents (β-sheet breaker peptides) which reverse the conformational change
leading to PrPSc. These observations virtually eliminate other hypotheses as
to the direct cause of TSEs, such as autoimmune disease of the central
nervous system, because those hypotheses do not incriminate the prion
protein. In both scrapie and vCJD, susceptibility and resistance to disease is
associated with polymorphisms within the prion protein gene (though no
such genetic susceptibility factors have yet been identified for BSE).
It remains possible that environmental factors, including toxic chemicals,
may additionally be implicated in susceptibility to prion disease.

v.   BSE is caused by a single strain of agent

Strain-typing in mice has shown that all sources of the BSE agent so far
examined produce the same lesion profile and incubation times in
experimental mice. The same strain has been identified in cats, which have
developed FSE since 1990, and in exotic ungulates and carnivores from
zoological parks.

vi. Variant CJD is caused by the BSE agent

Strain-typing studies in mice reveal that the disease patterns produced by the
agents causing BSE and vCJD are identical. The glycosylation patterns of
the prion protein associated with each condition are also identical and
different from other TSE strains. In transgenic mice in which the mouse
prion gene has been replaced by the bovine prion gene, inoculation with the
BSE agent from cattle brain produces the same disease pattern and
incubation period as agent derived from patients with vCJD. Following
inoculation with the scrapie agent, the incubation period and disease patterns
in the transgenic mice are markedly different from those produced by BSE
                                                                                 221
FINDINGS AND CONCLUSIONS


                and vCJD. In the absence of any other plausible factor, the evidence that
                BSE caused vCJD is so strong that all other hypotheses are now excluded.



         Alternative theories

         The organophosphate theory

         1123 The theory that BSE was caused by a reaction to the use of organophosphorus
         compounds (OPs) poured on cattle as systemic pesticides cannot be reconciled with
         the epidemiology and is not supported by research. One experiment has, however,
         given some limited support to the possibility that the OP phosmet might modify the
         susceptibility of cells to the prion disease agent.

         The autoimmune theory

         1124 There are a number of reasons why this theory does not seem viable,
         including:

            •   the fact that mouse-adapted BSE can be transmitted by intracerebral
                inoculation to mice lacking a functional immune system; and
            •   the fact that the theory is incompatible with what has been established about
                the central role of the prion protein in TSEs.



         Research
         1125 An important aspect of the response to BSE was the research that was
         undertaken in order to learn more about the disease. Before 20 March 1996 MAFF
         had funded over 120 research projects in relation to different aspects of BSE.
         Research work into TSEs, and more particularly BSE, was also funded by the
         Research Councils. We have not interpreted our terms of reference as requiring us
         to review the adequacy of all these projects. What we have explored are the broader
         questions of the funding, planning and coordination of BSE research. Our
         consideration of these topics is to be found in vol. 2: Science and vol. 11: Scientists
         after Southwood. Here we propose to do no more than set out a brief summary of
         our conclusions.

         1126 BSE did not emerge at a propitious time so far as research was concerned.
         In 1985 Ministers had accepted a recommendation from the Priorities Board for
         Research and Development in Agriculture and Food that expenditure on research
         into animal diseases was disproportionate and should be reduced by 20 per cent.
         Implementation of this policy was resulting in staffing cuts at research
         establishments.

         1127 The Neuropathogenesis Unit (NPU) in Edinburgh had been set up jointly by
         the Agricultural and Food Research Council (AFRC) and the Medical Research
         Council (MRC) in 1981 as an independent unit to study scrapie and the similar
222
                                                                         SCIENCE AND RESEARCH


human diseases of the central nervous system such as CJD. The need to relocate
staff and facilities and to build up suitable mouse colonies, coupled with financial
constraints on the appointment of necessary new staff, meant that it had not yet been
able fully to address this remit, although it had brought together a wide range of
expertise in genetics, strain characterisation and transmission of scrapie. In 1986,
however, it had been brought within the framework of the Institute for Research on
Animal Diseases, later to become the Institute for Animal Health. Shortage of
funding and the loss of independence had resulted in the disillusionment of its
Director, Dr Alan Dickinson, who resigned in 1987, and for whom for a long time
it proved impossible to find a suitable replacement. There was also uncertainty
about where the various parts of the new Institute should be located. Thus the
emergence of BSE found the NPU in a state of some disarray and with its future in
doubt.

1128 Despite these problems, both at the NPU and more generally, research into
BSE was not significantly impeded through lack of funding, although some research
projects got off to a slow start. An application for additional funds from the
Treasury Reserve was laboriously put together, finally presented in August 1989
and rejected. Alternative sources of funding were then identified, which involved
the diversion to BSE of funding earmarked for other projects.

1129 Between 1987 and 1996 the Government spent over £60 million on research
into BSE and other TSEs. Of this, £37.9 million was spent by MAFF and
£27.4 million funded by the Research Councils. DH’s expenditure was £1.6 million,
largely spent on funding the CJD Surveillance Unit (CJDSU).

1130 Almost all the research funded by MAFF was carried out either at the CVL
or at the NPU, with CJD research being carried out by the CJDSU. The BSE
research programme was developed within the CVL by the BSE Group, headed by
Mr Bradley, in consultation with the NPU. One project involved collaborative work
between the two laboratories. Priorities were allocated by the Tyrrell Committee.
The research that was carried out was extensive and wide-ranging, for example:

   •   It identified that BSE had the histopathology of a TSE.
   •   It quickly identified that BSE was transmissible to mice, both by inoculation
       and in feed.
   •   It identified that BSE was similarly transmissible to sheep and to goats.
   •   It confirmed the infectivity of brain and spinal cord and identified the
       infectivity of the distal ileum of calves.
   •   It identified that ½ gram would suffice to transmit BSE orally to a sheep and
       1 gram to a calf.
   •   It identified the fact that BSE was a single and distinctive strain of
       TSE agent.
   •   It swiftly identified the emergence of a new variant of CJD.
   •   It identified the link between vCJD and BSE.

1131 In 1990 Sir Donald Acheson set in train an initiative to place the AFRC/
MAFF/MRC research effort on BSE under the coordination of a single ‘director’.
                                                                                        223
FINDINGS AND CONCLUSIONS


         This met with resistance on the part of the Research Councils, which saw it as a
         threat to their independence, and was supported by MAFF only on condition that
         the director would report to the MAFF Minister. The proposal foundered. Instead it
         was agreed that SEAC would perform a limited role in facilitating interchange
         between the various bodies responsible for research. The demands on SEAC for
         advice were so onerous that members did not have the time to carry out a review of
         the adequacy of the research effort and to identify gaps in the research programme.
         The most that they were able to do was to check that the projects recommended by
         the Tyrrell Committee as having high priority were under way. In June 1992 they
         published a paper that recorded that they were ‘content with the progress of
         implementing the recommendations overall’.

         1132 We have concluded that it might have been advantageous to have had an
         individual or committee with a remit to coordinate research and to draw attention to
         research needs. As it was, these were largely identified by the CVL, which then
         played the role of contractor in supplying much of the research identified. Thus
         most of the projects were awarded without competition and were not peer-reviewed.
         We have identified, with hindsight, areas where research could profitably have been
         started earlier or been pursued with more vigour. Also, an attempt might have been
         made with advantage to recruit expertise from the wider scientific community. It is
         at least possible that had an overview been kept of all BSE research, some of these
         issues would have been identified and addressed at the time:

         1133 Scrapie-into-cattle transmission – Experiments to see if and how scrapie
         would transmit to cattle were begun in 1997. It would have been valuable to test the
         theory that BSE was caused by the scrapie agent or agents ten years earlier, although
         we accept that there were difficulties in the way of doing this.

         1134 BSE in sheep – The possibility that BSE might have been transmitted to sheep
         was recognised as early as 1987. So too was the risk that, if it had done so, it, like
         scrapie, might become endemic in sheep. Research to check whether this has
         happened is now being carried out. It is perhaps the most important unanswered
         question about the BSE epidemic.

         1135 Minimum infective dose – The NPU experiment to transmit BSE to sheep and
         goats, which was initiated in 1988, was, incidentally, a valuable test of whether a
         dose as small as that contained in ½ gram of material would transmit in feed across
         the species barrier. It was not, however, designed or used for the purpose of
         providing this information. The 1992 attack rate experiment was the first occasion
         on which MAFF sought to see how much infective material was needed to transmit
         BSE in feed, and even this was not designed to identify the minimum quantity.
         The results of the attack rate study were of great practical importance.

         1136 Sensitivity of the mouse bioassay – the infectivity of different tissues in
         BSE-infected cattle was tested by bioassay in mice. Tests begun in 1993 have
         demonstrated that mice are at least 1,000 times less susceptible to BSE than cattle.
         It would have been advantageous if the extent of this species barrier had been
         identified earlier.

         1137 Ante- and post-mortem tests for BSE – Simple ante- and post-mortem tests
         for BSE would have been of the greatest practical value. These are areas which
224
                                                                        SCIENCE AND RESEARCH


could have been developed with greater vigour and in which a research ‘supremo’
might have stimulated open competition.

1138 ELISA test for ruminant protein in compound feed – Research was carried on
‘in house’ at a leisurely pace. This was in part because the importance of developing
such a test was not appreciated until the significance of cross-contamination of feed
was brought home in 1994. A research director might have identified external
sources that would have advanced this area of research more rapidly.

1139 Epidemiology – One of the remarkable features of BSE research is that
the epidemiology was left largely to Mr Wilesmith and the members of his
small epidemiology department at the CVL. This perhaps reflected the lack of
veterinarian epidemiologists in this country. There was, however, scope for human
epidemiologists to address questions such as the cause of the BABs, the pattern of
the epidemic and the number of subclinical cases going into the human food chain.




                                                                                        225
      13. What went right and what
      went wrong?
      1140 In previous chapters we have described the BSE story. Here we review
      certain aspects of the story, discussing what went right, what went wrong, and why.
      We begin with the practice which ensured that BSE spread so widely – the use of
      meat and bone meal (MBM) in cattle feed. Then we look at the identification of
      BSE, and the major policy decisions, before considering what may have been the
      major causes of shortcomings. We conclude with general comments on the
      criticisms of individuals found elsewhere in our Report. An Inquiry inevitably
      focuses on shortcomings, and these comments are designed to redress the balance.



      A recipe for disaster

      1141 There is a body of opinion that believes that farmers had only themselves to
      blame for the epidemic of BSE. Cows are ruminants. They do not naturally eat
      animal protein. They were fed animal protein in order to boost their milk yield or
      fatten them up. Some say that it offended against nature to feed animal protein to
      ruminants. Some say that it was doubly offensive to turn grass-eaters into cannibals.
      Some say that it was not surprising that a plague was visited upon those that
      tampered with nature in this way.

      1142 Objection can be taken to many intensive farming practices on ethical or
      aesthetic grounds. We have resisted the considerable temptation to enter into this
      debate, which would take us well beyond our Terms of Reference. Of relevance to
      our Inquiry is the narrower question of why those responsible for the practice of
      using MBM in cattle feed did not foresee that this might be a recipe for disaster?

      1143 The MBM used in cattle feed was produced by rendering. This involved
      pooling and then processing material from hundreds, perhaps thousands, of animal
      carcasses at a time. As with other processes where ingredients are pooled, there is a
      risk of contaminating the pool if any single source is infective. It is thus of crucial
      importance to make sure that the rendering process will destroy any potentially
      harmful organisms or other agents in animal carcasses. This is particularly
      important if animal protein is being recycled within the same species, so that there
      is no species barrier to infection.

      1144 The suggestion has been made to us that the 1979 Royal Commission on
      Environmental Pollution warned against the risk of recycling animal waste. The risk
      to which the Commission drew attention was that of recycling poultry litter by
      including it as a protein supplement in ruminant feed. But the Committee went on
      to encourage this practice as an environmentally sound re-use of materials ‘given
      that care is taken to avoid health hazards’. An Agricultural Research Council report
      on ‘The Nutrient Requirements of Ruminant Livestock’ in 1980 drew attention to
      the value of undigested protein, of which MBM is a prime example, in ruminant
226   rations to promote milk and flesh production. This authoritative report by leading
                                                  WHAT WENT RIGHT AND WHAT WENT WRONG?


animal nutritionists, including the Agricultural Devolpment and Advisory Service
(ADAS), gave a boost to the use of MBM by feed manufacturers.

1145 The practice in the UK of recycling animal protein as an ingredient of animal
feed dates back to at least 1926. In the 1970s attention was directed within MAFF
to the danger that this practice would result in the spread of infectious diseases. The
diseases considered were those caused by conventional viral and bacterial
organisms. No consideration appears to have been given to the risk that scrapie
might be recycled in sheep, or even transmitted to other farm animals. This may
seem surprising. The answer probably lies in the fact that half a century had elapsed
without any indication that animal feed containing ovine protein was infecting
sheep or any other animal.

1146 The measure that MAFF introduced to address the risk of the spread of
infectious diseases as a consequence of incorporating MBM in feed was the
Diseases of Animals (Protein Processing) Order 1981. This laid down a mandatory
sampling regime designed to ensure that the rendering process inactivated all
conventional viral and bacterial pathogens. The measure was not designed to ensure
that the rendering process would inactivate Transmissible Spongiform
Encephalopathies (TSEs). No rendering process has yet been devised that will
guarantee to inactivate BSE.

1147 What went wrong was that no one foresaw the possibility of the entry into
the animal feed cycle of a lethal agent far more virulent than the conventional viral
and bacterial pathogens, and one which would be capable of infecting cattle despite
passing through the rendering process. When regard is had to the experience of
what, by 1981, was over 50 years of recycling of animal protein, we can understand
why the risk of a disease such as BSE was one which was not anticipated or
addressed by farmers, renderers, feed compounders, animal nutritionists or
government.



The identification of the disease and its cause

1148 Identification of the emergence of BSE was always going to pose a
challenge:

   •   It had a long incubation period.
   •   It tended to strike down a single animal in a herd.
   •   It produced clinical signs which resembled those of other conditions.
   •   It could only be identified as a TSE by histopathology.

1149 It is to the credit of the system of passive veterinary surveillance and the skill
of the Central Veterinary Laboratory (CVL) pathologists that the disease was
identified at a relatively early stage of the epidemic.

1150 Great credit is due to Mr Wilesmith for his rapid identification of MBM
in feed as the immediate source of infection. His individual contribution to the
response to the challenge of BSE was of the highest value. His deduction as to the
                                                                                          227
FINDINGS AND CONCLUSIONS


         probable reasons why MBM was infectious was reasonable, but wrong. It was
         unfortunate that his explanation – the scrapie theory – was one that provided
         unwarranted reassurance that BSE was likely to behave like scrapie and would thus
         not be transmissible to humans.

         1151 It was also unfortunate that, although problems with Mr Wilesmith’s theories
         became increasingly apparent to the scientists as more was learned about BSE, no
         reappraisal ever received publicity. When our Inquiry began, most members of the
         public remained under the impression that BSE was scrapie in cattle and that the
         reason why cattle feed had become infectious was that renderers had altered their
         methods of production to the detriment of safety standards.



         The Government’s response

         1152 In earlier chapters we have seen how the emergence of BSE confronted
         government with three challenges:

                •   how to eradicate BSE in cattle;
                •   how to address the possibility that BSE might be transmissible through
                    animal feed or otherwise to other animals; and
                •   how to address the possibility that BSE might be transmissible through
                    human food or otherwise to humans.

         1153 Those chapters summarise our discussion in Volumes 3 to 9 and 11 of the
         adequacy of the response to those challenges, having regard to the state of
         knowledge at the time. In the remainder of this chapter we draw attention to the
         major policy decisions in relation to these matters, which we have concluded were
         appropriate. We have shown that shortcomings attended the introduction,
         implementation, enforcement and monitoring of the measures pursuant to these
         decisions, and we identify some underlying features which led to shortcomings.

         Eradication of BSE

         1154 Banning the incorporation of ruminant protein in ruminant feed was the
         correct policy to adopt in order to eradicate BSE. Had it been fully implemented it
         would probably, by today, have achieved its object. As it is, it brought about a
         massive reduction in the number of new cases of infection so that, by 1996, it was
         apparent that the epidemic had been brought under control.

         1155 Precautionary measures could have been taken to address the possibility that
         BSE would prove to be maternally transmissible. Maternal transmission, of itself,
         might prolong but could not perpetuate the disease. It was reasonable to refrain from
         culling the offspring of BSE dams unless and until it was shown that maternal
         transmission was taking place on a scale that justified this. There was room for
         argument as to whether or not breeding from the offspring of BSE dams should be
         discouraged or forbidden, but this was not a major policy issue.


228
                                                  WHAT WENT RIGHT AND WHAT WENT WRONG?


1156 The possibility that BSE might be horizontally transmissible was addressed
by:

       •     guidance to farmers on preventing other cattle from coming into contact
             with the placenta of a calving dam; and
       •     a ban on the use of protein derived from Specified Bovine Offal (SBO)
             as fertiliser.

Possible transmissibility to other animals

1157 Although the primary motivation for the compulsory slaughter and
destruction of cattle showing signs of BSE was the protection of human health, it
had the added benefit that the carcasses of these animals could not be rendered for
animal feed. Thus this measure was in part a response to the possibility that BSE
would transmit to other animals.

1158 The measure specifically adopted to address this possibility was the animal
SBO ban. The object of the ban was to prevent the inclusion in animal feed of
protein derived from SBO. The leading pet food companies and the bulk of the
animal feed industry had previously adopted this ban on a voluntary basis. MAFF
made it compulsory after experimental transmission to a pig by inoculation had
been achieved. This ban affected predominantly the content of pig and poultry feed.
Although no express application of the ALARP principle was involved in this
decision, we consider that, if effective, it would have reduced the risk of
transmission of BSE to other animals through feed as low as was reasonably
practicable, having regard to:

       i.     the reasonable belief that BSE was unlikely to be zoonotic;
       ii.    the fact that there was no history of transmission of TSEs to, or
              experience of TSEs in, either pigs or poultry; and
       iii. the economics and waste disposal consequences of going further and
            imposing a total ban on including any animal protein in animal feed.

1159 Measures were also taken to reduce the risk of transmission of BSE to other
animals through veterinary medicines. Guidelines were issued to manufacturers of
both human (see below) and veterinary medicines, which advised that certain
bovine products should not be used in the manufacture of certain medicines,
suggested that action should be taken to reduce contamination in the collection and
production processes, and advised on sterilisation or discarding of the equipment
used.

Possible transmissibility to humans

1160 The principal policy decisions which addressed the possibility of
transmission of BSE to humans through food were those to introduce:

       i.     compulsory slaughter and destruction of cattle with symptoms of BSE;
              and
                                                                                       229
FINDINGS AND CONCLUSIONS


                ii.   the human SBO ban.

         1161 These were two vital measures for the protection of human health. Each was
         introduced at a time when the possibility that BSE might be transmissible to humans
         in food was considered remote. On that basis we consider that they constituted a
         proportionate response that satisfied the ALARP principle, albeit that the policy
         decisions did not result from the application of that principle. It is necessary,
         however, to go on to consider the decisions about which tissues should be
         proscribed as SBO.

         1162 For the reasons that we have set out earlier, we consider that the decisions
         about what should and what should not constitute SBO were reasonable, having
         regard to what was known at the time. It should be recognised that in drawing the
         line so as to exclude the abomasum, from which tripe and rennet were derived, and
         offal from calves aged less than 6 months, commercial considerations are likely to
         have weighed in the balance.

         1163 The possibility that BSE might be transmissible to humans through non-food
         products was addressed by issuing guidance to a number of relevant industries about
         the potential risk, including occupational risk, from the use of bovine products.
         Perhaps the most important was that issued to manufacturers of medical products,
         which, as we have noted, applied equally to medicines for human use and veterinary
         medicines.

         1164 The potential risk from occupational contact with bovine materials was also
         addressed by advice and guidance to many of those whose jobs brought them into
         contact with such materials. This advice was developed and issued over a period of
         time.

         1165 The final policy decisions with which we are concerned were those reached
         on 20 March 1996:

                i.    a requirement that carcasses from cattle aged over 30 months be
                      deboned in licensed plants supervised by the Meat Hygiene Service
                      (MHS) and the trimmings classified as SBO; and
                ii.   a prohibition on the use of mammalian MBM in feed for all farm
                      animals.

         1166 If there had been no need to consider practicality or public perception, a case
         could have been made for saying that the deboning scheme satisfied the ALARP
         principle. In the event it was not viable. On this occasion the wrong policy option
         was selected.

         1167 The prohibition on the use of mammalian MBM in feed for all farm animals
         was we consider an appropriate response under the ALARP principle to the change
         in knowledge of the risk posed by BSE to humans, consequent upon the conclusion
         of the Spongiform Encephalopathy Advisory Commitee (SEAC) that the cases of
         vCJD were probably linked to exposure to BSE.



230
                                                   WHAT WENT RIGHT AND WHAT WENT WRONG?


Shortcomings and possible reasons for them

1168 Putting hindsight aside, we have no doubt that the policy decisions that there
should be a ruminant feed ban, that clinically affected cattle should be destroyed and
that SBO should be kept out of human food and animal feed, were right. Because
the right policy decisions were taken, BSE is today within reach of eradication and
millions have received a high degree of protection from the risk of ingestion of
potentially infective products or by-products of the cow. This reflects credit on our
system of government and, in particular, on the State Veterinary Service (SVS),
which bore the brunt of the demands made on this country by BSE.

1169 Plaudits must, however, be muted. Not all went well. All too often the correct
policy decision was marred by:

   •   the time that had been taken to reach it;
   •   lack of rigour in considering how to give effect to it;
   •   lack of rigour in implementing, enforcing and monitoring the Regulations
       introduced to give effect to it.

1170 In order to see what lessons can be learned from the BSE story it is necessary
first to consider what may have been the major causes of the shortcomings that we
have identified.

Was there a conflict of interest in MAFF?

1171 We begin with a criticism that has been widely made of MAFF’s position in
relation to BSE. This starts with the complaint that MAFF had a conflict of interest
between the aim, on the one hand, of supporting producers of agricultural produce
(as ‘sponsor department’ for the industry) and, on the other, of protecting consumers
of agricultural produce. The criticism continues that in resolving that conflict
MAFF was more concerned to protect the interests of the producers.

1172 We discussed the question of conflict of interest with a number of witnesses,
including Sir Michael Franklin, who served as Permanent Secretary at MAFF up to
the end of September 1987. He accepted the potential for conflict of interest, but
commented:

       . . . you have to ask yourself whether it makes sense, and this is a great
       philosophical discussion on the machinery of Government, whether it is
       better to have these potentially conflicting interests in a separate department
       so that the tension is between the two departments, or whether it is better to
       have a single department with a single minister who can resolve those
       tensions within his own command. I have said earlier why I think, in terms
       of the food chain going from the farmer to the food industry and through to
       the rest of the food chain, there is in fact a positive advantage in having it all
       under one minister, and where tensions arise resolve them within the
       department.

1173 We do not propose to be diverted at this point into a great philosophical
discussion. At the general level, it should be recorded that Mr Gummer initiated            231
FINDINGS AND CONCLUSIONS


         measures which addressed this conflict by creating a separate Food Safety
         Directorate within MAFF and a Consumer Panel to advise the Ministry. We are
         concerned, though, to deal with the criticism that in the course of the BSE story
         MAFF leaned in favour of the agricultural producer to the detriment of the
         consumer. So far as the policy decisions are concerned we are satisfied that this
         criticism is without foundation. The ALARP principle does not aim to achieve zero
         risk. It involves an exercise in proportionality. For the reasons given earlier, we are
         satisfied that the consideration given to the details of the human SBO ban was a fair
         application of that principle. Once SEAC had been set up, MAFF’s approach was
         always to consult it on whether the risk BSE posed to humans called for further
         precautionary measures. Whether that was the best way to use SEAC, we shall
         discuss in due course. The fact is that MAFF never did less, and on occasion did
         more, than SEAC recommended. MAFF officials and Ministers were, in our
         judgement, as concerned as anyone else that if there was a possible risk to human
         health, appropriate measures should be taken in response to it. Concern for the
         industry meant, however, that officials and Ministers were particularly concerned
         about how the public would perceive the risk from BSE.

         Other conflicts of interest

         1174 Many Departments have potential conflicts of interest between responsibility
         for regulating an industry and being custodians of its interests within general
         government business. Examples in the BSE story included the dual role of the
         Department of Trade and Industry (DTI) on cosmetics and toiletries, and the
         multiple role of DH in fostering the pharmaceutical industry, looking after the
         interests of the NHS as a large-scale purchaser, and licensing individual products to
         safeguard consumers. Commonly, Departments seek to operate internal
         arrangements that keep the different roles separate. In the case of medicines, the
         ring-fencing arrangements, as we have seen, included heavy reliance on advice
         from statutory advisory committees of outside experts. This itself can create
         problems because many such experts may have their own financial links with
         companies for whom they are carrying out research or acting as advisers. There has
         been increasing emphasis on the need for all such interests to be declared when
         relevant to particular items under discussion.

         1175 We have seen no indication that vested interests were allowed to influence
         the approach to safety in these areas.

         Perception of risk

         1176 We have identified three types of challenge posed by BSE: the need to
         eradicate the disease, the potential threat to other animals and the potential threat to
         humans. The rigour with which each of these challenges was addressed was bound
         to be affected by the subjective belief of those involved as to whether BSE was, in
         fact, a potential threat to human life. We have formed the view that the vast majority
         of those who were involved in this country’s response to BSE believed,
         subjectively, that it was not a threat to human health. In their heart of hearts they felt
         that it would never happen – BSE was not, potentially, a matter of life and death for
         humans – and this belief was shared by many who could see, objectively, that the
         potential risk was there.
232
                                                 WHAT WENT RIGHT AND WHAT WENT WRONG?


1177 This view is based largely on impression as a consequence of having heard
oral evidence from those who were principally concerned. It is also supported by a
small statistical survey that we carried out. We asked more than 270 witnesses,
including those who were involved in the response to BSE either as Ministers,
officials or scientists advising government whether they had changed their diet as a
result of learning about BSE. All but a handful said BSE had had no relevant effect
on their diet.

1178 Although most of those concerned with handling BSE believed that BSE
posed no risk to humans and understood the available science as indicating that the
likelihood that BSE posed a risk was remote, they did not trust the public to adopt
as sanguine an attitude. Ministers, officials and scientific advisory committees alike
were all apprehensive that the public would react irrationally to BSE. As each
additional piece of data about the disease became available, the fear was that it
would cause disproportionate alarm, would be seized on by the media and by
dissident scientists as demonstrating that BSE was a danger to humans, and would
lead to a food scare or, even more serious, a vaccine scare.

1179 From the moment in December 1986 when Mr Bradley classified his first
minute about BSE as ‘Confidential’, to the Chief Medical Officer’s (CMO’s)
reassuring recorded message of 20 March 1996, ending with the statement ‘I myself
will continue to eat beef as part of a varied and balanced diet’, officials and
Ministers followed an approach whose object was sedation. In the first half of 1987
there were restraints on the release of information about BSE. After this there was
no attempt to conceal facts from the public. The approach did not set out to deceive.
It set out simply to redress the balance that it was feared would otherwise remain
tilted as a consequence of alarmist media cover. One witness described it nicely as
‘leaning into the wind’.

1180 Examples of this approach are legion. Here is a selection:

   •   The repeated statements that ‘there is no evidence that BSE is transmissible
       to humans’, which did not explain that such evidence would take many years
       to emerge.
   •   The repeated invocation of the assessment in the Southwood Report that ‘the
       risk to humans is remote’, which continued long after the assumptions made
       by the Southwood Working Party had been shown not to be valid.
   •   The agreed presentation of the human SBO ban as being a convenient means
       of giving effect to the baby food recommendation.
   •   Presentation of oral transmission of BSE to mice and transmission to a
       marmoset as demonstrating that BSE behaved like scrapie.
   •   Statements that the cat did not increase the likelihood of BSE transmission
       to humans.
   •   Dr Metters’s statement that: ‘Every effort has thus far been made to
       underline the Government’s position, based on advice from the Southwood
       and Tyrrell Committees, that the disease is not a risk to humans.’
   •   The attempt to get SEAC to produce publicity soundbites.

                                                                                         233
FINDINGS AND CONCLUSIONS


            •   The publicity documents submitted by MAFF officials to their Ministers on
                the very day in March when the balloon went up.
            •   The public presentation of the medicines guidelines as if they had secured
                the situation without indicating that products were not required to be
                withdrawn.

         1181 The campaign of reassurance focused particularly on the safety of beef.
         Successive DH CMOs, and a CMO for Scotland, made unqualified statements that
         it was safe to eat beef. They did so, not on the basis that they were satisfied that BSE
         was not transmissible in food, but on the basis that they were satisfied that the
         portions of the cow which might infect were not permitted to enter the food chain.
         This was not made clear to the public, who equated statements that it was safe to eat
         beef with statements that BSE posed no risk to humans.

         1182 The official line that the risk of transmissibility was remote and that beef was
         safe did not recognise the possible validity of any other view. Dissident scientists
         tended to be treated with derision, and driven into the arms of the media and to
         exaggerated statements of risk. Thus views expressed on risk became polarised.
         Dispute displaced debate.

         1183 The need to provide a reassuring message also featured strongly in the
         presentation of measures to ensure the safety of medicines. Concerns that the public
         might boycott vaccines if their safety was called into question were considered
         paramount.

         1184 The anxiety of Ministers and officials not to provoke alarm was shared by
         the scientific advisory committees. The Southwood Working Party told us that they
         did not wish to raise needless alarm in those who might have been infected with
         BSE before any precautionary measures were taken. They accommodated the
         concern of those responsible for advising on the safety of medicines that their
         Report should not suggest that vaccines posed any risk. Their Report gave the
         impression that in all circumstances the risk of transmission of BSE appeared
         remote. It had the caveats that they had had little evidence to go on and that, if their
         assessment were proved wrong, the implications would be extremely serious. These
         caveats were, however, quickly lost sight of. So that, for instance, the Committee
         on Safety of Medicines (CSM) in a position statement said: ‘The CSM agrees with
         the Southwood Working Party that the risk to man of infection via medicinal
         products is remote. As a precautionary measure, and for the sole aim of seeking to
         guard against what is no more than a theoretical risk to man, the CSM and the
         Veterinary Products Committee (VPC) have agreed joint guidelines on good
         manufacturing practice for the manufacturers of human and veterinary medicines
         who use bovine, or other animal materials either as an ingredient or in the
         production process.’

         1185 SEAC’s 1994 ‘Summary of Present Knowledge and Research’ on TSEs
         could have been the occasion for a public reassessment of the risk of transmissibility
         of BSE to humans in the light of all that had been learned since Southwood. It
         should have replaced the Southwood Report as the document to which anyone
         seeking an up-to-date and authoritative assessment of risk referred. But the message
         that it gave as to the reassessment of risk was muted and, so far as the public were
         concerned, it seems to have vanished without trace.
234
                                                WHAT WENT RIGHT AND WHAT WENT WRONG?


1186 What was the effect of the campaign of reassurance? The precautionary
measures that the Government introduced against the possibility that BSE might be
transmissible to humans called for care and diligence in their implementation and
enforcement. This was to be expected from those involved only if they were
persuaded that such a possibility was a real one and that the precautionary measures
were therefore important safeguards of human health. We have noted evidence from
those responsible for enforcing the SBO Regulations in slaughterhouses that BSE
was not regarded as a risk to human health. Local authorities told of the confusion
among their staff about the line to take. We have also identified areas where the
bureaucratic process ground on very slowly in responding to BSE – the preparation
of guidance on operational risks and dissecting bovine eyeballs are examples. In the
case of medicines and cosmetics, a relaxed attitude was taken to using up stocks.
We believe that lack of diligence in implementing Regulations and lack of urgency
in other areas of response to BSE were attributable, in part, to the success of
continuous efforts to make sure that news about BSE did not give rise to public
concern.

1187 We do not suggest that all were sedated by the official presentation of risk.
Some were sceptical and the media were not slow to point out that, while MAFF
persisted in maintaining that the risk to humans was remote, this message was
accompanied by a series of measures aimed at reducing risk still further.

1188 Whether they were sedated or sceptical, the reaction of many members of the
public to the announcement on 20 March 1996 was the same. They felt that the
Government had not been telling the truth about the risk to humans from BSE; the
public had been deceived.

1189 It is in the context of communication of risk that we feel that there is more
force in the argument that it was unsatisfactory for a single Department to be
concerned with protecting both consumers and producers. MAFF’s dual role meant
that their officials and Ministers were particularly apprehensive about the
possibility of alarmist consumer reactions causing harm to the producers. We note,
however, that DH officials who were not confronted with this potential clash of
interests with regard to food, showed themselves as eager as MAFF to present
information in a manner calculated to cause the least alarm.

1190 To an extent the Government’s response to BSE was driven not by its own,
and its advisers’, assessment of risk, but by the public’s perception of risk. The
introduction of the human SBO ban is the most notable example. At times media
response to BSE was exaggerated, but often media critique was pertinent and well
informed. The media played a valuable role in reflecting, and stimulating, public
concerns which proved well-founded and which had a beneficial influence on
government policy.

Ignorance and failures of communication

1191 Some of the responses to BSE were inadequate because those responsible for
them were not party to aspects of the state of knowledge at the time which should
have informed their decisions.

                                                                                       235
FINDINGS AND CONCLUSIONS


         1192 The earliest example of this was the delay in discovering the extent to which
         cattle were succumbing to BSE consequent upon restraints imposed at the CVL on
         dissemination of information about the disease in the first half of 1987.

         1193 Another example was the delay in deciding to introduce a slaughter and
         compensation policy, which resulted from the failure of MAFF officials to inform
         DH of the disease and to get its input into the consideration of BSE’s implications
         for human health.

         1194 A third example was the delay in addressing the risk from bovine products
         in human medicines, which resulted from that same lack of communication between
         MAFF and DH.

         Ignorance of views as to the minimum infective dose for
         cattle

         1195 A further example is provided by the consequences of the failure to focus on
         the question of the minimum infective dose. At the end of 1990 interim results of
         the Neuropathogenis Unit (NPU) experiment to transmit BSE to sheep and goats
         had indicated that eating infective material weighing only ½ gram had sufficed to
         infect a sheep. Had scientists at the NPU, or Dr Kimberlin, or Mr Wilesmith been
         asked in 1988, they would have advised that it was at least possible that the
         minimum amount of material that would suffice for oral transmission to a calf
         would be very small. Yet the result of the CVL attack rate experiment, which
         showed, at the end of 1994, that a single gram had transmitted BSE orally to a calf,
         caused widespread surprise and concern.

         1196 When the ruminant feed ban was introduced, some officials within MAFF
         were under the impression that a cow would have to eat a substantial quantity of
         infective material to contract BSE. This impression was shared by the UK
         Agricultural Supply Trade Association (UKASTA). It believed that the quantity of
         pig and poultry feed that might get into ruminant feed as a result of cross-
         contamination in feedmills was not a matter for concern. Mr Meldrum made the
         same assumption. The need to address the problem of cross-contamination of
         ruminant feed was not appreciated or tackled until 1994.

         1197 When the animal SBO ban was introduced in 1990, none of those involved
         appreciated the extent to which contamination of MBM with SBO in rendering
         plants would give rise to infectivity in that MBM, let alone that this would be
         enough to pose a threat to cattle as a result of a second round of cross-contamination
         in the feedmills. Steps were taken to agree a rendering code to reduce
         contamination, but not with any urgency, and two years elapsed from the
         introduction of the ban before the code was in place. Even this was insufficient to
         prevent significant contamination. Only after the result of the attack rate experiment
         became known in 1994 was the decision taken that renderers would have to process
         SBO in separate facilities.




236
                                                  WHAT WENT RIGHT AND WHAT WENT WRONG?


Ignorance of views as to the minimum infective dose for
humans

1198 The question of the minimum amount that was capable of infecting was
equally of importance in the context of the safety of human food. It was a vital
element in any evaluation of the potential risk of contamination of human food
by slaughterhouse practices, such as brain removal, and the production of
mechanically recovered meat (MRM).

1199 In 1989, when the SBO Regulations were being prepared, the safety of MRM
received consideration, which we have concluded was inadequate. Scientists were
not asked for their views of the minimum amount which might infect. An
assumption was made that any contamination of MRM with spinal cord was
unlikely to be sufficient to be significant. In the following year MAFF officials
adopted a similar approach to the question of contamination as a result of head-
splitting and brain removal.

1200 SEAC’s robust advice, that removing the brain before the head meat was not
acceptable, gave some indication that the Committee considered that a small
quantity of contaminant was cause for concern. SEAC never so stated expressly,
and its paper on the safety of beef was capable of conveying the false impression
that only a substantial quantity of infective material would pose a risk of
transmission by the oral route.

Ignorance of pathways of infection

1201 One of the questions asked by Sir Richard Southwood before the first
meeting of his Working Party was:

       What are the routes to man of parts/products of cattle, especially dairy cattle,
       before and after slaughter?

1202 MAFF and DH were unable to provide a detailed reply. He was told that there
was a very low probability that spinal cord formed part of meat products, but that
quantitative information on the fate of organs and tissues was unavailable. Since
1996 a survey has disclosed that, at the time that the Southwood Working Party
were considering their recommendations, substantial quantities of spinal cord were
going into human food as an ingredient of MRM. Had the Working Party known
this we wonder whether they would have been content that it should be allowed to
continue.

1203 The Tyrrell Committee advised, as a top priority item, that there should be a
more detailed investigation into the fate of bovine (and ovine) tissues and products
that could lead to infection being spread by as yet unrecognised routes. This
recommendation was never implemented. Had it been, timely consideration might
have been given to closing pathways of potential infection for humans or for
animals that, at least initially, were overlooked.

1204 In June 1990 a survey of cutting procedures disclosed that lymph nodes
removed in the course of dressing meat were used in meat products for human
consumption.                                                                              237
FINDINGS AND CONCLUSIONS


         1205 In 1994 members of SEAC were concerned to learn that the residues that
         settled in the tank bottoms in the course of refining tallow, including tallow derived
         from SBO, was still being incorporated in cattle feed.

         1206 Until 1995 it was not appreciated by MAFF officials that gelatine derived
         from cattle was entering cattle feed in substantial quantities as an ingredient of
         recycled waste foods, in breach of the ruminant feed ban.

         1207 Uncertainty prevailed throughout the period with which we are concerned as
         to the use of bovine products in cosmetics.

         1208 Consideration was not given to the question of whether drainage waste from
         slaughterhouses or effluent from renderers of SBO might pose hazards of BSE
         contamination which called for review of their disposal.

         Failures of communication

         Between the Southwood Working Party, the Government and the
         public

         1209 Many who read, or who were informed of the conclusions of, the Southwood
         Report failed to appreciate that:

            •   When describing the risk posed by BSE to humans as remote, the Working
                Party intended to indicate that such precautions as were reasonably practical
                should nonetheless be taken to address the risk.
            •   The description of the risk from medicinal products and occupational
                exposure as remote was predicated on the assumption that the responsible
                authorities had been alerted to the potential risk and were taking appropriate
                measures to address it.
            •   The Working Party’s conclusions on risk were based on very limited data
                and were inferences drawn from knowledge of scrapie and CJD.
            •   The Working Party contemplated the possibility that their conclusions might
                be wrong, and that in that event the implications would be extremely serious.

         Between SEAC, the Government and the public

         1210 The breakdown of communication between MAFF officials and SEAC,
         when the latter considered slaughterhouse practices and MRM, resulted in the
         impression being given that the members of SEAC were not concerned by the
         degree of contamination described as ‘inevitable’ in MAFF’s paper on the topic.
         That was not the position. Some, at least, of the members of SEAC were advising
         on the premise that there would be total removal of the spinal cord before MRM was
         extracted. They gave the same advice about MRM on the same basis in June 1995.
         Not until November 1995 was it brought home to SEAC that spinal cord was not
         always being cleanly removed, whereupon at last it advised against the practice of
         extracting MRM from the bovine vertebrae.

238
                                                 WHAT WENT RIGHT AND WHAT WENT WRONG?


1211 We have commented above on the possibility that SEAC’s 1990 paper on the
safety of beef contributed to the erroneous belief that a substantial quantity of
infective material would have to be eaten in order to transmit BSE.

1212 SEAC’s 1994 paper on TSEs failed to spell out clearly that events since the
Southwood Report had adversely altered the assessment of the likelihood that BSE
was transmissible to humans, and this message was not conveyed to the general
public.

Lack of rigorous consideration when giving effect to policy

1213 We have identified three occasions on which a lack of rigour when
considering how to implement policy had adverse consequences. The first was at
the time of the introduction of the ruminant feed ban. Because of the lengthy
incubation period, years would necessarily elapse before any defects in the
operation of the ban would become apparent. The technique of building a dam and
then looking for leaks would not do. Rigorous consideration should have been given
to ensuring that the dam was watertight in the first place. The question of whether
cross-contamination in feedmills would be cause for concern should have been
addressed. Advice should have been obtained on how much contaminant might
suffice to infect. This would have led to UKASTA being advised that cross-
contamination had to be prevented and focused attention on the urgency of
developing a test that would detect ruminant protein in compound feed.

1214 The second occasion was when the question of the safety of MRM was raised
in the course of the consultation exercise for the human SBO ban. The critical issues
of the extent of likely contamination of MRM and the minimum amount of material
that might infect were not addressed. It was simply assumed that any contamination
would be too small to matter. Thus no guidance was given to local authorities or the
Veterinary Field Service as to the importance of removal of all spinal cord.

1215 On these first two occasions the lack of rigour resulted in failure on the part
of those considering the implementation of policy to obtain the information that was
available and was needed in order to reach the correct decision.

1216 The third occasion was the preparation of the Order that was to give effect to
the animal SBO ban. The terms of the Order were in a form that was unenforceable.
Rigorous consideration would have led to the conclusion that this was not a ban
where self-policing could be relied upon and that Regulations should be drawn up
which could be enforced.

The best being the enemy of the good

1217 The production of written documents by officials and by advisory
committees frequently entailed a process of wide consultation and drafting
refinement. This was a ‘Rolls-Royce’ system, but one which tended to result in
lengthy delays. Consultees would be tempted to suggest drafting improvements,
which would then result in a further round of consultation. These were often not
changes of sufficient substance to justify the delay that they caused.

                                                                                        239
FINDINGS AND CONCLUSIONS


         1218 One area in which the effects of this were keenly felt was in the preparation
         of written guidance on precautionary measures and practices. On some occasions it
         took many months, or even years, after a decision was taken to issue written
         guidance, for that decision to be implemented. By way of example, it took two-and-
         a-half years for SEAC’s advice on the dissection of bovine eyeballs to be passed on
         to schools and up to three years to issue simple occupational warnings and basic
         advice to some of the high-risk trades.

         1219 When drafts were submitted to advisory committees for comment, delays
         could be particularly protracted. Again, by way simply of example, we can cite the
         comprehensive advice of the Advisory Committee on Dangerous Pathogens
         (ACDP) to those handling risk tissues in laboratories, hospitals and mortuaries. A
         further example is an excellent draft Advisory Note to farmers on the dangers of
         cross-contamination of cattle feed with pig or poultry feed that was initially drafted
         in November 1995, was considered and refined by, among others, both SEAC and
         Mrs Browning, and had not been issued by 20 March 1996. In all of these cases the
         desire to perfect a document was allowed to outweigh the need for speedy advice.
         The best became the enemy of the good.

         Inappropriate use of advisory committees

         1220 Advisory committees have a vital role to play in assisting government to
         formulate policy. However, if matters are referred to committees which only meet
         periodically, this can delay the process of taking decisions. We shall give detailed
         consideration to the lessons to be learned in relation to the use of committees at
         a later stage. For present purposes we would draw attention to the following
         principles:

            •   resort should be had to committees only where their expertise is needed;
            •   advice sought should be clearly targeted so as to fall within the expertise of
                the committee;
            •   advice given should be reviewed to ensure that it appears to be soundly
                based; and
            •   advice should be treated as such, and not as being determinative of policy.

         1221 These principles were not always followed in the case of the BSE story. For
         example:

                i.   In order to resolve the policy issue of whether cattle showing signs of
                     BSE should be permitted to enter the human food chain, the essential
                     question to answer was whether it was possible to be confident that this
                     would involve no risk. There was no need to appoint the Southwood
                     Working Party to resolve that question. MAFF officials had been able
                     to reach a firm, and correct, conclusion on the limited available data that
                     it was not. Had DH officials been involved with MAFF in considering
                     the risk to human health from the outset, we believe that they would
                     have concurred in that conclusion. The decision to refer the question to
                     a Working Party resulted in a delay of over three months.

240
                                                                          WHAT WENT RIGHT AND WHAT WENT WRONG?


            ii.    The conclusions of the Southwood Working Party were not reviewed.
                   Their recommendations were treated not as advice, but as definitive of
                   the precautionary measures which did, and did not, require to be taken.
                   It was left to public reaction, and the assistance of Dr Kimberlin through
                   the good offices of Pedigree Masterfoods, the pet food manufacturer, to
                   lead MAFF Ministers to conclude, over three months later, that an SBO
                   ban should be imposed.
            iii. The advice of the Southwood Working Party continued to be quoted as
                 definitive of the precautionary action required by science long after
                 some of the premises upon which the Working Party had advised were
                 demonstrated to be unsound.
            iv. SEAC was set up as a standing, part-time, committee to advise MAFF
                and DH on ‘matters relating to spongiform encephalopathies’. The
                breadth of these terms of reference was reflected in the wide variety of
                matters on which SEAC was asked to advise.103 It immediately became
                the practice to seek the advice of SEAC on any policy decision that had
                to be taken in relation to BSE, without identifying those aspects of the
                question on which SEAC was particularly qualified to advise or
                targeting the advice sought from it. Furthermore, once SEAC had
                advised, its recommendations tended to be treated as determinative of
                the action to be taken.

1222 On two occasions the intervention of SEAC proved positively unhelpful. The
first was when slaughterhouse practices including MRM were referred to it. The
untargeted request to SEAC to advise ‘whether any action or guidance is necessary
in relation to slaughterhouse practices’ led to advice being given on the basis of
SEAC’s assessment of the efficacy of those practices. This assessment was
unreliable and was one that MAFF officials were very much better placed to
perform. The advice was not in clear terms and led MAFF officials wrongly to
conclude that members of SEAC were not concerned about inevitable failure to
remove all spinal cord before MRM was extracted from the vertebrae.

1223 The second occasion was when SEAC recommended the deboning scheme
on 20 March 1996. This was unhelpful because the Government accepted it without
time to review it to decide if it was practically and politically viable. In this context
we would quote a pertinent observation made by the Agriculture Committee in its
1990 Report:

            Scientists do not automatically command public trust, particularly when they
            are in disagreement with each other, and when the issues concerned do not
            lend themselves to simple yes/no answers but involve computations of
            whether particular risks are acceptable or unacceptable to members of the
            public. Decision-making is not a purely scientific process.

1224 By the time that the 20 March policy decision came to be made, the reliance
by government on SEAC to answer questions of policy had become so well
established that officials and Ministers had been waiting to see what SEAC had to
say rather than carrying out their own exploration of the policy options by way of
contingency planning.

103
      The use of SEAC receives detailed consideration in vol. 11: Scientists after Southwood             241
FINDINGS AND CONCLUSIONS


         Administrative structures

         Interdepartmental structures

         1225 Evaluation of whether, and in what respects, BSE posed a risk to humans
         was, in theory, primarily the responsibility of DH, but turned largely on questions
         that fell within veterinary expertise. Evaluation of whether, and in what respects,
         BSE posed a risk to other animals fell wholly within MAFF’s responsibility and
         turned, to a large extent, on the same questions of veterinary expertise. Risk
         management in relation to both types of risk, as far as animals and food products
         were concerned, fell almost entirely within MAFF’s area of responsibility, while
         DH took the lead on other areas, in particular human medicines. Occupational risk
         fell somewhere between these two Departments and the Health and Safety
         Executive (HSE). We have already observed, however, that it is difficult to draw the
         line between risk evaluation and risk management. It was important that MAFF and
         DH worked closely together. In particular, so far as food risks were concerned, DH
         needed to be satisfied that MAFF was taking appropriate action by way of risk
         management to ensure that potential food risks were satisfactorily addressed.

         1226 So far as medicines were concerned, the licensing divisions of the two
         Departments were responsible for implementing the same legislation using the
         same assessment criteria – safety, quality and efficacy. A similar system of statutory
         advisory committees applied, and the Medicines Commission spanned both human
         and veterinary medicines, having an overview of the workings of the system as a
         whole. Moreover, veterinary and human medicines drew on similar raw materials,
         types of sterilisation and production processes. This called for a coordinated
         approach between the two.

         1227 The need for such cooperation between MAFF and DH must exist in relation
         to other zoonoses, as well as BSE.

         1228 Relations between MAFF and DH with regard to BSE did not fall within the
         framework of any formal interdepartmental structure for dealing with known
         zoonoses or potentially zoonotic animal diseases. If there had been satisfactory
         interdepartmental communication and collaboration on an informal basis, this
         would not have mattered. As we have pointed out, however, until Sir Donald
         Acheson was notified about BSE in March 1988, such communication and
         collaboration were absent. Had there been an effective interdepartmental body
         concerned with zoonoses and potential zoonoses, the BSE story might have got off
         to a better start. That does not, of itself, demonstrate the need for such a body – it
         raises the question of whether a formal structure may not be the best way of ensuring
         proper interdepartmental collaboration in this field.

         1229 Matters were further complicated when other Departments were involved.
         The response on cosmetics called for effective communication and coordination
         between MAFF, DH and DTI, the industry’s sponsor Department. Similarly, it was
         for DES to send out advice on the dissection of bovine eyeballs in schools, drawing
         on advice from DH, MAFF and the HSE. On waste disposal the Department of the
         Environment was involved. All this called for clear allocation of lead responsibility
         and efficient lines of communication between Departments. These were not always
         evident.
242
                                                                            WHAT WENT RIGHT AND WHAT WENT WRONG?


DH role

1230 DH104 had the lead in relation to human health surveillance, being the
Department to which the CJD Surveillance Unit reported. On most other aspects of
BSE, DH maintained a watching brief over MAFF’s actions. As Sir Christopher
France105 told us, it was for the Chief Medical Officer and the professional staff who
reported to him to take the lead on the DH response to BSE. In the early stages of
the story Dr Pickles, who had the DH lead, played a notably proactive role in
scrutinising and questioning MAFF’s actions. As we discuss in Chapter 6, in the
weeks leading up to March 1996 the DH role was passive, with the result that they
did not raise with MAFF the need for contingency planning as soon as it became
apparent that BSE might prove to be transmissible to humans.

1231 The other major area in which DH took the lead was in relation to human
medicines. Veterinary medicines were to some extent treated as the poor relation of
human medicines. MAFF from the beginning of 1989 took its cue from DH on the
handling of existing products and stocks in relation to BSE. Within DH, medicines
licensing was the province of Medicines Division (MD), which, as one witness put
it, ‘consumed its own smoke’. When reviewing products over which any questions
arose, MD looked to advice from its ‘section 4 committees’ of eminent outside
experts. During the period with which we are concerned there was a significant
reorganisation of the arrangements for handling medicines licensing, in order to
address structural and management problems identified in a management review.
MD was reconfigured into an Executive Agency – the Medicines Control Agency –
in 1991, and the Medical Devices Agency followed in 1994. This reorganisation
itself led to some upheaval and confusion, which did not facilitate the management
of the BSE measures.

1232 It seemed to us that clearer expectations about reporting to top management
and to Ministers would have assisted in the handling of BSE and medicines. By way
of example, had Ministers been asked explicitly to consider whether existing stocks
of vaccines should continue to be used while guaranteed ‘clean’ replacements were
procured, we believe they would have taken a keen interest in the follow-up. This
in turn might have influenced the subsequent pace of events and perhaps led to the
doubtful material being phased out rather more quickly than in fact happened.

Structure within MAFF

1233 During the period with which we are concerned, Mr Gummer sought to
separate MAFF’s sponsorship role from its role in protecting the consumer, by
creating a new Food Safety Directorate. Within that Directorate there were what on
the face of it appeared to be significant structural changes within MAFF whose aim
was to improve the way administrators and veterinarians interrelated.106 It had
originally been suggested that the CVL and the Veterinary Investigation Service
(VIS) should merge into a single Executive Agency. The SVS, however, had
successfully made its case that it should retain the VIS within its structure.
Administrators and veterinarians were, however, merged into the Animal Health
and Veterinary Group in 1990, only to be sundered again in 1994. Most witnesses
considered that neither change had much effect on how the two worked together in
104
      See vol. 15, Chapter 4 and Annex 1 for details of the interrelationship of professionals and administrators within DH
105
      DH Permanent Secretary to February 1992
106
      See Vol. 15: Government and Public Administration for details of the interrelationship of professionals and administrators
      within MAFF                                                                                                                  243
FINDINGS AND CONCLUSIONS


         practice. On a day-to-day basis the Chief Veterinary Officer had direct access to the
         Minister, and would assist him or her with professional advice in relation to policy
         decisions. Major issues of policy would be put before Ministers in formal
         submissions prepared by administrators with the assistance of professional advice
         from the veterinarians. A rather similar approach was followed in preparing papers
         for SEAC – the paper on slaughterhouse practices is a good example.

         1234 So far as the quality of the advice was concerned, this system worked well.
         However, it was, as we have noted, a ‘Rolls-Royce’ system. Drafts were circulated
         and recirculated among a large number of officials, who might have input to
         contribute. Submissions were refined, polished and supplemented with minutes as
         they passed up the administrative hierarchy on their way to the Minister. The
         process could take a very long time.

         1235 Where urgency was perceived, it was possible to cut through the red tape and
         reach a decision fast. This had its own dangers. Mr Gummer’s insistence that the
         Government should announce its response to SEAC’s advice on transmission of
         BSE to a pig simultaneously with announcing that advice, led to defective
         Regulations, prepared ‘in secrecy and haste’ without the normal consultation.
         Similar haste for a similar motive led to the announcement of a response which
         proved unviable in March 1996.

         Chief Medical Officers and Chief Veterinary Officers

         1236 The evidence we have heard about the parts played by the CMO and CVO in
         the BSE story suggests that consideration should be given to two aspects of their
         roles. It is not our function to define their roles in the abstract, as we have noted in
         Volume 6 in relation to the CVO.

         1237 The first aspect calling for consideration is their ability to give independent
         advice to the public. Mr Meldrum, at least, considered that the CVO did not have
         the degree of independence afforded to the CMO in stating publicly his opinions.
         Indeed, Mr Meldrum has assumed that the CMO was required to advise the public,
         independent of government, even though this might cause difficulty for his
         Department, or other Departments. We are not aware of any secure basis for saying
         that the CMO can do this. This may be contrasted, by way of example, with the
         position of the Food Standards Agency, one of the functions of which is to advise
         the general public. The Agency also has a power to publish such advice. We think
         it desirable that the CMO and CVO should be in the same position.

         1238 The second aspect relates to the effect of the relative status of the CVO and
         CMO. We note that the CVO is an official of high standing in the international
         arena, but we understand from the evidence we have heard that under civil service
         conventions the CVO ranks only with the deputy CMO. We feel it is important that
         this should pose no impediment to direct liaison between the CVO and CMO.

         Central and local government

         1239 The greatest impediment to the efficacy of the Government’s response to the
         emergence of BSE was the structure laid down by statute for the enforcement of the
244      Regulations that were designed to keep potentially infective tissues out of both
                                                 WHAT WENT RIGHT AND WHAT WENT WRONG?


human food and animal feed. The first and most critical control point was the
slaughterhouse. In the slaughterhouse, the critical point for human health was the
inspection and health-stamping of meat as fit for human consumption. For animal
health, the critical control point was the gut room, where in practice, though not by
any requirement of the Regulations, most of the SBO should have been kept
segregated from material to be rendered to produce MBM for animal feed, and
where, in accordance with the Regulations, the SBO should have been stained
black.

1240 The statutory duty of enforcing the human SBO ban, together with many
other Regulations relating to standards and practices in slaughterhouses, rested on
the District Councils. In order to comply with European requirements, which were
widely considered to be unnecessarily burdensome, District Councils had to employ
an enforcement hierarchy, with the Official Veterinary Surgeon at the top. Local
authorities faced severe budgeting constraints. Slaughterhouse supervision did not
assert a strong claim in the competition for their limited funds, and in a climate of
deregulation there was no encouragement from central government to accord
priority to this issue. Most councils spent no more than was barely essential to cover
enforcement duties in slaughterhouses. Some did not spend that much. When the
MHS took over enforcement, it found that insufficient resources had been employed
by at least some local authorities to ensure that the obligation imposed by the human
SBO ban to remove all spinal cord from the carcass was universally enforced. It also
found that familiarity with the Regulations, efficiency of line management and
diligence on the part of local authorities in enforcing the Regulations were uneven
across the country.

1241 Had the importance of the removal of spinal cord been emphasised in
guidance to local authorities and to the Veterinary Field Service (VFS), which
monitored performance, we believe that standards could have been improved, but
only within limits. The limitations on the enforcement capability of local authorities
could only have been remedied had they been persuaded to devote more resources
to that task. We can see no way in which that goal could have been achieved.

1242 Turning to the animal SBO ban, the structural problems were that much
greater. The County Councils responsible for enforcing that ban had no locus in the
slaughterhouse. The District Councils were not in general enthusiastic about doing
their job for them. The situation was exacerbated by the fact that the terms of the
animal SBO ban imposed no obligations in the slaughterhouse, but we agree with
Mr Meldrum and Mrs Attridge that, however well drafted the Regulations, the
statutory structure of local authority enforcement would have prevented strict
enforcement of the animal SBO ban.

1243 In this situation, monitoring by central government of the performance by
local authorities of their enforcement obligations was desirable. MAFF Ministers
thought the same, so far as concerned Regulations sponsored by their Department,
and required the SVS to perform a monitoring role. The shortcomings in monitoring
which we identify in vol. 5: Animal Health, 1989–96 might well have been reduced
if that monitoring had had a statutory foundation.



                                                                                         245
FINDINGS AND CONCLUSIONS


         Central government and the Territorial Departments

         1244 We have seen that the Territorial Departments were for the most part content
         to follow the lead of MAFF and DH with regard to BSE. Nonetheless, we have also
         seen that communication between Whitehall and the Territories was not always
         satisfactory. DH was not always interested in the views of the Territorial
         Departments. This was particularly unfortunate with regard to Wales, where the
         combination of skills and experience in the Welsh Office allowed its professionals
         and administrators to make some very useful and pertinent comments. It might well
         have been beneficial had these been taken on board by DH.



         Individual criticisms: redressing the balance

         1245 It is inevitable that an Inquiry such as ours focuses on what went wrong. The
         main point of having the Inquiry is to find out what went wrong and to see what
         lessons can be learned from this. This can be harsh for individuals. Their
         shortcomings are put under the spotlight. The overall value of the contributions that
         they have made is lost from view. We do not wish our Report to produce this result.
         Yet we cannot set out in detail the workload over the years of each of those who has
         received – at one point or another – a criticism in our Report. We must make some
         general comments.

         1246 The more senior posts in the civil service are seldom sinecures. Ministerial
         office never is. We have limited our consideration of individual responsibility to
         those who occupied such positions. The shortcomings that we have criticised have
         not been the product of indolence; they have for the most part been mistakes made
         under pressure of work – pressure made the greater by the imposition on already
         busy lives of the considerable additional burdens of handling BSE.

         1247 The day-to-day demands made by BSE on MAFF, and particularly on the
         State Veterinary Service, were considerable. By way simply of example, in the
         period with which we are concerned approximately 200,000 suspect cattle had to be
         inspected, slaughtered and autopsied by histopathology. The carcasses had to be
         collected and destroyed. Compensation had to be assessed and paid.

         1248 Between 1988 and 1995 about 30 Statutory Instruments in Great Britain
         alone were brought into force making or amending Regulations dealing with BSE.
         Some of these involved a great deal of work, but more significantly they evidence
         the ongoing attention being focused on addressing the implications of BSE for both
         animal and human health during a period when it was considered unlikely that BSE
         was in fact a threat to humans. Thus the individual criticisms that we have made
         must be read in the context of participation in a positive response to BSE, which on
         the one hand brought the animal disease under control, and on the other resulted in
         the removal from human food and from medicines of a very high proportion of the
         material that might have had the capacity to infect.

         1249 There are aspects of the response to BSE that stemmed from broader
         government policies, or from particular ways of handling the problem. Again, these
         may not be matters that give rise to individual criticism, but they may well highlight
246      lessons for the future. For example, we have noted that Ministers often sought
                                                  WHAT WENT RIGHT AND WHAT WENT WRONG?


policy advice from SEAC during most of the period. A lesson we have drawn from
this is that where the policy decision involves the balancing of considerations which
fall outside the expertise of the committee, it will normally not be appropriate to ask
the committee to advise which policy option to adopt. It is not our job to examine
broad government policies, for example the deregulation initiative. Where relevant,
we have examined their implications for the BSE story. For example, our
consideration of the impact of the deregulation initiative for slaughterhouses is in
Volume 6.

1250 Those who were most active in addressing the challenges of BSE are those
who are most likely to have made mistakes. As was observed in the course of the
Inquiry, ‘if you do not put a foot forward you do not put a foot wrong’. In this
context we think it right to single out for mention Mr Meldrum. Mr Meldrum was
Chief Veterinary Officer in Great Britain for almost the whole of the period with
which we are concerned. He involved himself personally in almost every aspect of
the response to BSE. He placed himself at the front of the firing line so far as risk
of criticism is concerned.

1251 Mr Meldrum impressed us as a particularly dedicated and hard-working civil
servant. We are aware that many consider that he epitomises an approach on the part
of MAFF that placed more weight on the interests of the farmer than on the safety
of the consumer. We do not consider such an accusation to be fair.

1252 Mr Meldrum was at all times concerned that the livestock industry should not
be damaged by a public reaction to BSE for which there was, in his opinion, no
scientific justification. That is not an approach for which Mr Meldrum can be
criticised. On the contrary, we consider that it was a proper approach for the
Chief Veterinary Officer to adopt.

1253 In the BSE story there were a number of issues on which Mr Meldrum
advanced the view that the possibility of risk to humans was too insignificant to
warrant precautionary measures:

   •   Should offal of sheep be removed from human food?
   •   Should tripe and rennet from the abomasum be included in the SBO ban?
   •   Should tissues from calves under the age of 6 months be excluded from the
       SBO ban?
   •   Was MRM a risk to humans?

1254 We do not doubt that the views which Mr Meldrum advanced reflected his
own beliefs.

1255 When Mr Meldrum had concerns about risks to humans, he acted on them.
Thus:

   •   He recommended that there should be no exclusion from the SBO ban of
       intestines that had been procured to produce sausage skin.
   •   In 1990 he raised concerns in relation to peripheral nervous tissue going into
       MRM.
                                                                                          247
FINDINGS AND CONCLUSIONS


            •   In 1994 he raised the suggestion of banning recovery of MRM from the
                spinal column.

         1256 We are satisfied that where Mr Meldrum perceived the possibility of a
         significant risk to human health he gave this precedence over consideration of the
         interests of the livestock industry.

         1257 Pressures on busy people go some way to mitigate a number of other
         criticisms that we have made – for example, the failures to review the Southwood
         Report, and failures to give rigorous consideration to the form of the animal SBO
         ban.

         1258 We have criticised the restrictions on dissemination of information about
         BSE in the early stages of the story, which were motivated in part by concern for
         the export market. We suspect that this may have reflected a culture of secrecy
         within MAFF, which Mr Gummer sought to end with his policy of openness. If
         those we have criticised were misguided, they were nonetheless acting in
         accordance with what they conceived to be the proper performance of their duties.

         1259 For all these reasons, while we have identified a number of grounds for
         individual criticism, we suggest that any who have come to our Report hoping to
         find villains or scapegoats, should go away disappointed.




248
14. Lessons to be learned
1260 We have reached the final chapter of this volume – consideration of the
lessons to be learned from the events that we have been considering. First we
summarise lessons from particular episodes of the story and then lessons to be
learned about five topics which run right through the story: the use of advisory
committees; dealing with uncertainty; legislative loopholes; crisis management;
and the experience of the victims of vCJD and their families.

1261 Aspects of this Inquiry make this an unusual and not entirely satisfactory
exercise. The BSE story is an ongoing story. We have looked at a substantial section
of the story, but one that ended over four-and-a-half years ago. We have conducted
a particularly public Inquiry and believe that, while it has been proceeding, many
lessons have already been learned from the BSE experience and acted upon. The
scenery has shifted very considerably from that with which we have made ourselves
familiar. The most significant changes have been the creation of the Food Standards
Agency and the devolution of powers to a Scottish Parliament and Welsh Assembly.
We have also been informed of the creation of a large number of interdepartmental
bodies, covering areas which include zoonoses, animal disease surveillance and
Transmissible Spongiform Encephalopathy (TSE) research.

1262 The Office of Science and Technology has addressed the questions of the
Government’s use of science, the Government’s use of expert committees and the
Government’s approach to risk. These topics have also received consideration by a
number of other institutions.

1263 It is not part of our remit to assess how well all these developments are now
working. That is for others, including the Government, press and public. We
propose to confine ourselves strictly to the lessons to be learned from the BSE
experience up to 20 March 1996. If some of these lessons have already been learned,
others may bear repeating.



Episodes in the BSE story

Lessons from the fact that BSE emerged

Commentary

1264 The fact that the origin of the BSE epidemic is unknown leaves many
questions unanswered. In particular it raises the possibility that rare cases of
autosomal genetic mutation may give rise to sporadic TSE in cattle, and possibly in
other animals.




                                                                                       249
FINDINGS AND CONCLUSIONS


         Lessons

            •   BSE is a novel and alarming zoonosis. There is much about it that is not
                yet understood. Precautionary measures need to be applied to reduce the
                potential risk to as low as is reasonably practicable.
            •   TSEs may occur in species in which they have previously been unknown.
            •   It is possible that TSEs develop sporadically in other animal species as they
                do in humans.
            •   If TSEs develop sporadically and rarely in farm animals, as they do in
                humans, they may well pass undetected. This is particularly the case where
                farm animals are slaughtered for consumption when young and thus before
                clinical signs normally develop.

         Lessons from the transmissions of BSE

         Commentary

         1265 We have now learned much about the capacity of BSE to transmit to other
         animals, both naturally and experimentally. The lessons learned provide valuable
         data for risk management.

         Lessons

            •   TSEs may be transmissible between the same species and between different
                species.
            •   TSEs may be transmissible within animal feed and human food.
            •   Tissues in an animal incubating a TSE may be infectious before the animal
                has developed clinical signs of the disease.
            •   It is possible to distinguish between the level of infectivity, or titre, likely to
                be found in the different tissues of an animal incubating a TSE. The brain
                and spinal cord, in the later stages of incubation, are the highest risk tissues.
            •   A very small quantity of infective material may be sufficient to transmit a
                TSE by the oral route.
            •   Risk of oral transmission of a TSE will be greatly reduced if high risk tissues
                are removed from the food chain.

         Lessons from the spread of the BSE epidemic

         Commentary

         1266 What turned the initial case or cases of BSE from an incident into a
         catastrophe was the wide, and latent recycling consequent upon the practice of using
         meat and bone meal (MBM) as an ingredient of animal feed.

250
                                                                        LESSONS TO BE LEARNED


Lessons

   •   The process of rendering animal parts to produce MBM, which is then
       incorporated in animal feed, will result in the pooling of material from many
       animals and the wide dissemination of infection from a single infective
       animal.
   •   The rendering process cannot be relied upon to inactivate TSEs.
   •   Recycling animal protein carries a greater risk of spreading infection with a
       TSE when it is carried out within the same species.
   •   Recycling animal protein carries a greater risk of spreading infection with a
       TSE where the protein is derived from high-risk tissues.
   •   Where a TSE has a lengthy incubation period, recycling may spread the
       disease very widely before its emergence is detected.

Lessons from the identification of BSE

Commentary

1267 The identification of the emergence of a new animal TSE was of critical
importance as the first step towards addressing the implications of the disease. The
importance of a surveillance system that will identify the emergence of new animal
diseases was demonstrated. The efficacy of the passive surveillance system depends
upon farmers and their veterinarians drawing incidents of animal disease to the
attention of the State Veterinary Service (SVS). When a new disease is identified,
early publication of information about its characteristics will be desirable in order
to encourage reporting of similar cases.

1268 We note with satisfaction the consideration currently being given to
surveillance by the circulation of a consultation document: Veterinary Surveillance
in England and Wales – A Review, April 2000. We emphasise the importance of
pursuing this initiative.

Lessons

   •   An effective system of animal disease surveillance is a prerequisite to the
       effective control of animal diseases.
   •   An effective system of passive surveillance will depend upon farmers and
       their veterinarians having the incentive and the facility for drawing instances
       of animal disease to the attention of the SVS.
   •   Research into methods of diagnosis should form an integral part of an animal
       disease surveillance system.
   •   The proximity of the nearest veterinary centre of investigation to the farm
       where the disease occurs will be an important factor in determining whether
       or not a casualty is referred for pathological examination.
   •   The identification of BSE demonstrated the importance of the animal disease
       surveillance system of the SVS and of the close links that existed between
                                                                                         251
FINDINGS AND CONCLUSIONS


                the Veterinary Investigation Centres (VICs) and the Central Veterinary
                Laboratory (CVL).
            •   It is important that details of a new disease which may have implications for
                human and animal health should be disseminated within the State and private
                veterinary systems in order to encourage the reporting of similar cases.

         Lessons from the consideration of the nature and
         implications of BSE

         Commentary

         1269 When BSE was identified as a new disease by the CVL in December 1986,
         it was at once appreciated that two important questions needed to be answered. Was
         it indeed a TSE? And did it have implications for human health? It was the greatest
         good fortune that, as a result of the joint initiatives of the Agricultural and Food
         Research Council (AFRC) and the Medical Research Council (MRC), there existed
         in the form of the Neuropathogenesis Unit (NPU) a world-renowned centre of
         expertise in TSEs. We have criticised the delay in seeking the collaboration of the
         NPU in answering the first important question. We have also criticised the more
         substantial delay in involving DH in the consideration of the second question.

         Lessons

            •   Where animal or public health is at stake, resort should be had to the best
                source of scientific advice, wherever it is to be found, without delay.
            •   Collaboration between MAFF and DH, and between the Chief Veterinary
                Officer (CVO) and the Chief Medical Officer (CMO), must be maintained
                in considering the potential for animal diseases to threaten human health and
                the steps that should be taken in response to any potential zoonosis.
                Consideration should be given to whether a formal structure is the best
                means of achieving this.
            •   Advantage should be taken of the expertise and resources of the Public
                Health Laboratory Service (PHLS) whenever the possibility of a potential
                zoonosis exists.
            •   Lead responsibility must be clearly established for coordinating the
                scientific response to a new disease or a new outbreak of disease.
            •   Consideration should be given to combining in the same laboratory research
                on scientific issues that have common application to human and animal
                health by scientists practising in each field.

         Lessons from the investigation of the cause of BSE

         Commentary

         1270 The investigation of the cause of the cases of BSE that were being reported
         in 1987 and 1988 was carried out by Mr Wilesmith. He was the only veterinarian
252
                                                                        LESSONS TO BE LEARNED


on the staff of the SVS who had a postgraduate qualification in medical
epidemiology. He told us of the dearth of veterinarians trained in epidemiology and
of the absence of any training courses in veterinary epidemiology. Dr Tyrrell told
us of the initial impossibility of finding a veterinary epidemiologist of high calibre
to serve on the Spongiform Encephalopathy Advisory Committee (SEAC).

1271 The result was that the burden of the epidemiological investigation of BSE
was shouldered by Mr Wilesmith, with the help of his subordinate staff, throughout
the period with which we are concerned. The data on which he worked were not
readily available to others interested in the epidemiology of the disease.

1272 Mr Wilesmith quickly and correctly identified MBM as the vector of BSE.
His tentative conclusions as to why the MBM was infective proved to be erroneous.
They were reasonable on the data available to him, but could profitably have been
subject to epidemiological review as more data became available to which
modelling could be applied.

Lessons

   •   Provision should be made for training veterinarians in epidemiology. Joint
       postgraduate training programmes in epidemiology for trainees in veterinary
       medicine and public health medicine should be encouraged.
   •   Epidemiologists, particularly those in the public sector, should make
       available the data upon which their conclusions are based.

Lessons from the introduction of the ruminant feed ban

Commentary

1273 When the ruminant feed ban was introduced, it was not appreciated that there
was any need to be concerned about the amount of cross-contamination of cattle
feed likely to occur in feedmills from the production of pig and poultry feed
containing MBM. This was because it was assumed that the quantity involved
would not be sufficient to result in transmission. There was a general impression
that a large quantity of contaminated material had to be eaten in order to transmit
this disease. There was no basis for this assumption, which should not have been
made. Had rigorous thought been given to the matter, this would have involved
seeking the views of the experts, who would have advised that a small quantity
might suffice to infect.

Lessons

   •   When a precautionary measure is introduced, rigorous thought must be given
       to every aspect of its operation with a view to ensuring that it is watertight.
   •   Reliance on a trade association or other body to communicate the importance
       of a precautionary measure is not always appropriate.


                                                                                         253
FINDINGS AND CONCLUSIONS


         Lessons from the introduction of slaughter with
         compensation

         Commentary

         1274 The decision that cattle showing clinical signs of BSE should be
         compulsorily destroyed was too long delayed. One reason was that DH was not
         involved until a very late stage. We have already referred to the need to maintain
         joint MAFF/DH involvement in dealing with potential zoonoses. Another cause of
         delay was the reference to a Working Party of the question of how to respond to
         BSE when the input of the Working Party was not essential to the decision on
         compulsory slaughter.

         Lessons

            •   Where policy decisions turn on risks to human health, DH should be
                involved in the formulation of policy from the outset.
            •   Reference to outside expert committees involves delay. It should be avoided,
                where possible, in a situation of urgency.
            •   Uncertainty can justify action.

         Lessons from the Southwood Report

         Commentary

         1275 We have drawn attention in Chapter 4 to certain aspects of the Southwood
         Report which detracted from its overall merit. We shall deal in due course in more
         detail with lessons to be learned in relation to the use of expert committees
         generally. We set out here those derived specifically from the Southwood Report.

         Lessons

            •   An advisory committee should draw a clear distinction between any
                information provided by others, which it has not reviewed, and its own
                conclusions.
            •   An advisory committee should explain the reasoning on which its advice is
                based.
            •   When giving advice, an advisory committee should make it clear what
                principles, if any, of risk management are being applied.
            •   An advisory committee should not water down its formulated assessment of
                risk out of anxiety not to cause public alarm.




254
                                                                                 LESSONS TO BE LEARNED


Lessons from the introduction of the animal SBO ban

Commentary

1276 The animal SBO Order suffered from fundamental defects which rendered it
unenforceable. It was prepared in haste and without consultation. It was also
prepared without the rigorous thought that should have been given to the need to
introduce Regulations that were enforceable and the manner in which the
Regulations should have achieved this.

Lessons

      •     Where a precautionary measure is introduced, rigorous thought must be
            given to every aspect of its operation with a view to ensuring that it is fully
            effective.
      •     If this cannot be done before the measure is introduced, it should be done as
            soon as possible afterwards.

Lessons from the implementation and enforcement of the
animal SBO ban

Commentary

1277 The widespread disregard, both deliberate and accidental, of the animal SBO
ban, was due in part to defects in the Regulations, in part to lack of enthusiasm
among local authority inspectors and in part to lack of rigour by the Veterinary Field
Service (VFS) in monitoring enforcement. We believe that the VFS’s lack of rigour
was in part a consequence of the fact that it had no statutory monitoring function
and no right of access to slaughterhouses.

Lessons

      •     When Regulations that have implications for human or animal health fall to
            be enforced by local authorities:107

                       – clear guidance should be given to the local authorities as to the
                         importance of the Regulations and the manner of their
                         enforcement;

                       – there should be statutory provision enabling central government
                         to monitor the standards of compliance and enforcement.

      •     Measures that depend on particular slaughterhouse procedures being
            followed need to be based on informed understanding of practical working
            conditions.



107
      This lesson is derived equally from the enforcement of the human SBO ban                   255
FINDINGS AND CONCLUSIONS


         Lessons from the introduction of the human SBO ban

         Commentary

         1278 We have been critical of the fact that the merit of the introduction of this
         precautionary measure was diminished by:

                i.    the delay in appreciating that it was desirable to introduce a ban,
                      consequent upon failure adequately to review the Southwood Report;
                ii.   the public presentation of the reason for the ban, which suggested that
                      it was not an important public health measure; and
                iii. the failure to identify that the practice of mechanical recovery of meat
                     called for special consideration.

         Lessons

            •   Government Departments must retain ‘in house’ sufficient scientific
                expertise to enable them to understand and review advice given by advisory
                committees.
            •   Government Departments must review advice given by advisory committees
                to ensure that the reasons for it are understood and appear to be sound.
            •   Where a precautionary measure is introduced, rigorous thought must be
                given to every aspect of its operation with a view to ensuring that it is fully
                effective and its purpose and application understood by those concerned.
            •   Government Departments should clearly tell both the public and those
                responsible for enforcement the reasons for, and the importance of, any
                precautionary measures that they introduce.

         Lessons from the final months

         Commentary

         1279 The Government was taken by surprise and wrong-footed by the
         announcement by SEAC that a new variant of CJD had been identified which was
         probably linked to BSE. It should not have been. The growing apprehension that
         this might be the case had been expressed by Dr Will and other members of SEAC
         at its meetings on 5 January 1996 and, more forcibly, 1 February. Representatives
         of MAFF and DH present at those meetings did not put their colleagues on the alert
         that SEAC might be moving towards this conclusion. The possibility of this should
         nonetheless have been appreciated by those who received the reports of the SEAC
         meetings. They did not, however, consider any contingency plans. There were no
         interdepartmental discussions about the gathering storm. Everyone waited to see
         what SEAC had to say.




256
                                                                       LESSONS TO BE LEARNED


Lessons

   •   Departmental representatives attending meetings of advisory committees in
       the capacity of secretariat or observers should see that their Departments are
       promptly informed of any matters which may require a response from
       government.
   •   Contingency planning is a vital part of government. The existence of
       advisory committees is not an alternative to this. The advisory committees
       should, where their advice will be of value, be asked to assist in contingency
       planning.

Lessons in respect of Wales, Scotland and Northern Ireland

Commentary

1280 An outbreak of an infectious animal disease may pose threats over a wide
geographical area and the effectiveness of the response must not be inhibited by
purely administrative boundaries. BSE proved to be a UK-wide problem and the
lessons to be learned are those which relate to such a problem.

1281 It will usually be desirable where there is a problem common to the UK
threatening animal health, or both animal and human health, that a common solution
should be found, that the same legislative measures should be introduced at the
same time and that enforcement standards should be similar.

1282 When BSE emerged, the Territories were, in general, content to follow the
lead of MAFF and DH. Under devolution a similar attitude cannot be relied upon.
SEAC’s advice was the critical element in the formulation of policy, but SEAC
reported only to MAFF and DH. We do not consider that this was the most
satisfactory arrangement then and it certainly would not be satisfactory today.
Moreover, information and expertise existed in the Territories that might usefully
have informed UK policy-making. It is important that advice and information
should be shared by all those who are responsible for animal and human health in
the United Kingdom.

Lessons

   •   Arrangements need to be in place which will facilitate a synchronised
       approach throughout the United Kingdom to common problems of animal
       health, or animal and human health.
   •   Advisory committees set up to advise on problems of animal health, or
       animal and human health, which are common throughout the United
       Kingdom should report to the appropriate Departments both in England and
       in the Territories.
   •   So far as animal diseases, particularly those which may involve risk to
       human health, are concerned, a clear understanding should exist as to:
       i.   the identification of those areas where a uniform and synchronised
            policy and/or implementation is required and who is to take the lead;
                                                                                        257
FINDINGS AND CONCLUSIONS


                ii.   the sharing of resources and information;
                iii. a structure for consultation and joint decision-making that minimises
                     unnecessary delay.

         Lessons from the emergence of vCJD

         Commentary

         1283 The transmission of BSE to humans was considered most unlikely, but it has
         happened. The normal incubation period is not yet known, though if that of kuru is
         any guide, it is likely to be long. It is too early to estimate the number of people who
         are at present incubating the disease.

         Lessons

            •   Although likelihood of a risk to human life may appear remote, where there
                is uncertainty all reasonably practicable precautions should be taken.
            •   Precautionary measures should be strictly enforced even if the risk that they
                address appears to be remote.
            •   All pathways by which vCJD may be transmitted between humans must be
                identified and all reasonably practicable measures taken to block them.
            •   The needs of victims of vCJD and their families have special features.
                Consideration should be given to how best the health and welfare services
                can meet them. Patients for whom a care plan has been carefully arranged
                have received better management than those for whom this is lacking.

         Lessons from the handling of non-food routes of
         transmission to humans

         Commentary

         1284 The widespread use of bovine material for a whole range of food and non-
         food purposes created a large number of potential pathways of infection of BSE to
         man. The same is true of any potentially zoonotic disease. Handling of the risks to
         humans calls for the identification of all such pathways, availability of appropriate
         powers to address the risks and clear allocation of responsibility for doing so.

         Lessons

            •   A comprehensive review to identify all the potential pathways of infection
                to humans, including those from waste disposal, for a potentially zoonotic
                disease should be undertaken as a basis for taking steps to prevent
                transmission. This review should involve all relevant Departments and draw
                on outside expertise as necessary.


258
                                                                         LESSONS TO BE LEARNED


   •   An overall handling plan with consistent objectives and a timetable should
       be drawn up and lead responsibility for dealing with each pathway clearly
       allocated.
   •   The legislation applicable to different types of product may provide differing
       and sometimes inconsistent powers for dealing with similar risks or raw
       materials. Consideration should be given to the need for a power to cut off
       supply of a widely used but potentially toxic raw material at source.
   •   Occupational health risks should be considered in relation to each of those
       pathways and advice or warnings be promptly provided.

Lessons from the approach to BSE and medicines

Commentary

1285 A potential zoonosis with a long incubation period throws up particular
problems for the systems that exist to ensure the safety of human and veterinary
medicinal products. While Medicines Act licensing decisions need to be insulated
from undue pressures, they also need to be taken on a fully accountable basis.

Lessons

   •   Reliance on reported adverse reactions will not result in the timely
       identification of problems arising from a disease with a long incubation
       period. A database of concerns other than those resulting from adverse
       reactions should be considered.
   •   The licensing authorities, their advisory committees and others involved in
       the medicines licensing system each have information and expertise in
       relation to potential zoonoses that will be of use to the other. Effective action
       in respect of such diseases depends on this being shared. MAFF, DH and the
       Medicines Commission should consider what improvements might be
       needed to existing collaborative arrangements.
   •   It is not always clear in practice where responsibility rests as between
       Ministers, officials and advisory committees for advising, determining
       policy and taking key decisions on medicines. This should be clarified, so as
       to ensure that important policy decisions are taken by, or approved by,
       Ministers, whether those decisions are to take action or to take no action.
   •   The extent of the requirements of confidentiality in relation to the licensing
       of medicines should be reviewed.
   •   Medicines Advisory Committees should make clear what is a scientific
       assessment and what is a value judgement, so that value judgements are not
       treated as expert assessments of risk.
   •   Ring-fencing of medicines decisions to insulate them from outside pressures
       can reduce accountability. There should be properly reasoned and recorded
       decision-taking, and the criteria being applied should be made openly
       available.

                                                                                           259
FINDINGS AND CONCLUSIONS


            •   Thought should be given to ways of ensuring that those licensing animal-
                derived medicinal products are properly informed about the sources and
                collection of materials.

         Lesson from the approach to BSE and cosmetics

         Commentary

         1286 Addressing the possible risks posed by BSE in relation to cosmetics was
         impeded by lack of knowledge about the cosmetic products available, their
         composition and uses.

         Lesson

            •   DTI should review the need to maintain data on products which offer a
                potential pathway of infection.

         Lesson from the approach to BSE and occupational risk

         Commentary

         1287 Delays in drafting and issuing guidance in respect of occupational risks posed
         by BSE were inordinate.

         Lesson

            •   The Health and Safety Executive (HSE) should consider means of ensuring
                that the issue of guidance in respect of risks impacting on different
                occupations is carried out in a manner which is coordinated and expeditious.

         Lesson in relation to pollution and waste control

         Commentary

         1288 The pathways by which the BSE agent might come into contact with humans
         and animals as a consequence of the disposal of waste did not receive adequate
         consideration prior to March 1996.

         Lesson

            •   The disposal of waste from any processing of material that may contain the
                BSE agent should be reviewed to ensure that it does not involve risk of
                infection of humans or animals.




260
                                                                       LESSONS TO BE LEARNED


Lessons in relation to research

Commentary

1289 We have noted the very large number of research projects that were
undertaken in response to BSE. We have also drawn attention to a number of areas
where, with hindsight, we can see that research could profitably have been started
earlier or pursued with more vigour. Had an improved structure for research
coordination been in place, many of these deficiencies might have been avoided.

Lessons

   •   Where a problem in animal and human health arises that leads to demands
       for research of the scale and diversity required by BSE, it is desirable that
       Government Departments and Agencies coordinate their efforts.
   •   Coordination of the research effort is desirable in order to achieve:

              – identification of gaps in research;

              – determination of research priorities;

              – identification of the best sources of expert assistance;

              – a well-constructed plan for funding from the outset;

              – competition for research projects;

              – peer review of projects; and

              – efficient arrangements for provision of clinical material to
                researchers.

   •   The progress of research and the implications of any new developments must
       be kept under continuous and open review.
   •   Our conclusion that BSE was probably present in the cattle herd in the 1970s
       may have implications for past and current assessments of risk which have
       assumed that the earliest date of infection was around 1980. This illustrates
       the importance of setting out assumptions and keeping them under review.
   •   What is now known about the relative sensitivity of mouse bioassay
       compared with calf bioassay may have implications for the conclusions
       drawn from mouse bioassays. These need to be reconsidered systematically.

The use of scientific advisory committees

Commentary

1290 Volume 4 of our Report deals in detail with the assistance provided by the
Southwood Working Party and Volume 11 with the assistance provided by the
                                                                                       261
FINDINGS AND CONCLUSIONS


         Tyrrell Committee and SEAC. The Government relied heavily on the advice of
         SEAC during most of the period with which we are concerned, and in Volume 11
         we discuss, with commentary, the lessons to be learned from the use of this
         Committee. We shall not repeat that commentary here, but briefly itemise the
         lessons which apply to such committees.

         Lessons

                     Setting up the committee

               •     The areas of advice that are required from the advisory committee should be
                     identified as precisely as possible before the committee is set up.
               •     The terms of reference should specify with as much precision as possible the
                     role of the committee.
               •     The composition of the committee should include experts in the areas of the
                     advice that is likely to be required.
               •     Those invited to join a committee should be given a realistic estimate of the
                     commitment required.
               •     A lay member can play a valuable role on an expert committee.108
               •     Government should seek advice from the professional or other body best
                     qualified to advise on suitable candidates for membership.
               •     Potential conflicts of interest should not preclude selection of those members
                     otherwise best qualified, but conflicts of interest should be declared and
                     registered.
               •     Where any item of business involves an apparent conflict of interest on the
                     part of a member, that should be declared.
               •     Where the workload of a committee is considerable, it is reasonable that
                     members who are not public servants should be remunerated.
               •     It will often be desirable to draw the secretariat from the commissioning
                     Department(s) in order to provide a two-way channel of communication.
               •     In such cases, as in all cases, the secretariat must be careful to respect the
                     independence of the committee.

                     The role of the committee in relation to policy

               •     Where a policy decision is urgent, consideration should be given to whether
                     delaying the decision pending advice from an advisory committee is the best
                     course.
               •     Consideration should be given at the outset to the manner in which the
                     committee will contribute to deciding policy.
               •     Government should recognise that if a committee is asked to advise which
                     policy option to adopt, there may be little alternative but to follow the advice
                     given.


262      108
               See the section below on ‘Dealing with uncertainty and the communication of risk’
                                                                   LESSONS TO BE LEARNED


•   Where the policy decision involves the balancing of considerations which
    fall outside the expertise of the committee, it will normally not be
    appropriate to ask the committee to advise which policy option to adopt.
•   It may be appropriate to ask the committee to set out a range of policy
    options, together with the implications of each.
•   Where advice is sought on the implications of policy options, this may best
    be achieved by dialogue between government and the committee.
•   Where advice is required only on those ingredients of a policy decision
    which fall within the particular expertise of the committee, questions should
    be formulated with precision to achieve that result.
•   Where a Department has concerns about the practical implications of advice
    that a committee may give, these should be placed openly before the
    committee.
•   Where a committee is asked to advise on risk management, it will normally
    be helpful for the committee to follow a formal structure based on recognised
    principles of risk assessment.

    The form of the advice

•   Advice should normally be given in writing.
•   Advice should be in terms that can be understood by a layperson.
•   Advice should clearly state the reasons for conclusions.
•   Assumptions underlying advice should be made clear.
•   Advice should identify the nature and extent of any areas of uncertainty.
•   Where appropriate, the advice should set out the different policy options and
    the implications of each.

    Communication of the advice

•   The advice of the committee, together with any papers necessary for the full
    understanding of that advice, should be circulated to all within government
    with responsibility for policy decisions in respect of which the advice is
    relevant.
•   The advice of the committee should normally be made public by the
    committee.
•   The proceedings of the committee should be as open as is compatible with
    the requirements of confidentiality.




                                                                                    263
FINDINGS AND CONCLUSIONS


                Review of the advice

            •   Departments should retain ‘in house’ sufficient expertise to ensure that
                the advice of advisory committees, and the reasoning behind it, can be
                understood and evaluated.
            •   Advice given by a committee should be reviewed by those to whom it is
                given to ensure that the reasons for the advice are understood and appear
                sound.
            •   Where the reasoning of the advice of a committee is unclear, clarification
                should be obtained from the committee.

         Dealing with uncertainty and the communication of risk

         Commentary

         1291 Some argue that it is not the task of government to protect the public against
         risk in circumstances where the individual can accept or avoid the risk by making
         his or her own informed choice. Where the hazard is transparent and one that the
         individual can readily avoid, this argument has force. Most people believe,
         however, that government has an important role to play in reducing the extent to
         which the consumer is exposed to hazard. They believe, for instance, that the
         Government should do all that is reasonably practicable to see that the food that they
         eat and the medicines that they take are reasonably safe.

         1292 The Government adopted this approach in seeking to protect the public from
         the possibility that BSE might pose a hazard to human health. We have already
         considered the extent to which the way that it set about achieving that objective was
         an adequate response to the emergence of BSE. At this point we are concerned with
         the lessons to be learned from one aspect of the response that proved particularly
         unsatisfactory – communication of risk to the public. Although we have made a
         number of individual criticisms in respect of risk communication, the lessons to be
         learned are based on hindsight and relate to the overall approach of reassurance that
         was adopted. We do not consider that individuals should be criticised for following
         that approach.

         1293 The problem is not an easy one. The public are anxious to understand the
         basis upon which the Government’s decisions on risk management are taken. The
         Government does not set out to achieve zero risk, but to reduce risk to a level which
         should be acceptable to the reasonable consumer. The individual consumer wishes
         to be satisfied that the Government has drawn the line in the right place. How can
         the Government best satisfy the public that this aim has been achieved? We
         discussed this question with a number of witnesses.

         1294 Throughout the BSE story, the approach to communication of risk was
         shaped by a consuming fear of provoking an irrational public scare. This applied not
         merely to the Government, but to advisory committees, to those responsible for the
         safety of medicines, to Chief Medical Officers and to the Meat and Livestock
         Commission. All witnesses agreed that information should not be withheld from the
         public, but some spoke of the need to control the manner of its release. Mr Meldrum
264      spoke of the desirability of releasing information ‘in an orderly fashion’ – of
                                                                         LESSONS TO BE LEARNED


ensuring that the whole package of information was put together, taking care in the
process not to ‘rock the boat’.

1295 Mr Brian Dickinson, who was a member of MAFF’s Food Safety Group, put
the matter in this way:

       Given the strength of public debate on the matter at the time one was aware
       of slightly leaning into the wind. You could not just stand upright and give a
       totally impartial, objective view of what was the situation. There was a
       stronger danger of being misinterpreted one way rather than the other, and
       we tended to make more reassuring sounding statements than might ideally
       have been said.

1296 We felt that this was an accurate description of the general approach to risk
communication. We have seen that it provoked increasing scepticism and, on
20 March 1996, the reaction that the Government had been deceiving the public.

1297 In discussing this topic with us, Sir Robert May, Chief Scientific Adviser,
expressed the following view:

       You can see the temptation on occasion to wish to hold the facts close so that
       you can have internal discussion and the formation of a consensus so that a
       simple message can be taken out into the market place. My view is strongly
       that that temptation must be resisted, and that the full messy process whereby
       scientific understanding is arrived at with all its problems has to be spilled
       out into the open.

1298 This view received strong support from representatives of the consumer
organisations. They emphasised the need for open scientific debate. Ms Sheila
McKechnie, the Director of the Consumers’ Association, emphasised the need to
develop a culture of trust. She commented that:

       There is nothing more nanny-ish than withholding information from people
       on the ground that they may react irrationally to that information.

1299 She made the point that organisations build up credibility by openness. She
expressed the hope that the Food Standards Agency would achieve this.

1300 Everyone agreed that the Government had a problem with credibility. A
number of Government Ministers told us that they had lost credibility with the
public, so that it was necessary to get independent experts to lend credibility to
public pronouncements about risk. Mrs Bottomley spoke of the need for the public
to receive information free of ‘political overtones’. She told us that she did all that
she could to promote the Chief Medical Officer as an independent expert who could
be trusted by the nation.

1301 Our experience over this lengthy Inquiry has led us to the firm conclusion
that a policy of openness is the correct approach. When responding to public or
media demand for advice, the Government must resist the temptation of attempting
to appear to have all the answers in a situation of uncertainty. We believe that food
scares and vaccine scares thrive on a belief that the Government is withholding
information. If doubts are openly expressed and publicly explored, the public are         265
FINDINGS AND CONCLUSIONS


         capable of responding rationally and are more likely to accept reassurance and
         advice if and when it comes. We note, by way of example, that SEAC and MAFF
         have made public the fact that an investigation is being carried out into the question
         of whether BSE has passed into sheep. We do not understand that this has led to a
         boycott of lamb.

         Lessons

            •   To establish credibility it is necessary to generate trust.
            •   Trust can only be generated by openness.
            •   Openness requires recognition of uncertainty, where it exists.
            •   The importance of precautionary measures should not be played down on the
                grounds that the risk is unproved.
            •   The public should be trusted to respond rationally to openness.
            •   Scientific investigation of risk should be open and transparent.
            •   The advice and the reasoning of advisory committees should be made public.
            •   The trust that the public has in Chief Medical Officers is precious and should
                not be put at risk.
            •   Any advice given by a CMO or advisory committee should be, and be seen
                to be, objective and independent of government.
            •   The role, if any, of the Chief Veterinary Officer in making public statements
                in relation to risk to human health from a zoonosis or potential zoonosis
                should be clarified.
            •   The activities of the Meat and Livestock Commission (MLC) in the period
                up to 20 March 1996 do not appear to have represented all its statutory
                objectives. The MLC has submitted to us proposals in relation to its future
                role. We recommend that these receive consideration in the light of our
                Report.

         The legislative framework

         Commentary

         1302 The Government’s response to BSE adopted different approaches to dealing
         with the risk that the BSE agent in cattle incubating the disease or showing signs of
         it might be transmitted to other animals or to humans.

            •   Cattle showing clinical signs were compulsorily slaughtered and destroyed.
            •   The incorporation of high-risk tissues from apparently healthy cattle in
                human food was forbidden.
            •   The incorporation of ruminant protein in feed for ruminant animals was
                banned.
            •   The incorporation of high-risk tissues from apparently healthy cattle in
266             animal feed was banned.
                                                                       LESSONS TO BE LEARNED


   •   The disposal of high-risk tissues was regulated so that, in effect, they could
       only be disposed of as waste.
   •   The use of bovine products or by-products of UK origin in the manufacture
       of medicinal products was phased out in compliance with guidelines.
   •   Recovery of mechanically recovered meat (MRM) from the spinal column
       of cattle was forbidden.

The problem

1303 The statutory powers relied on in adopting these measures were enacted in
order to deal with known hazards. However, while it was established that BSE was
a major disease threat to cattle, it was for several years unknown whether it was a
hazard to human beings and other animals, and if so, how great a risk it posed. The
generally held belief of the Government’s scientific and veterinary advisers was that
BSE probably did not pose a risk to human beings, pigs or poultry. Moreover, even
the risk to cattle was not fully established; it was unknown whether BSE could
infect cattle other than by some form of ingestion. Thus an unusual feature of the
BSE story was that the Government imposed Regulations to address risks that
scientists believed probably did not exist, or at least could not confirm as probably
existing.

1304 The Government had to take action on BSE in the face of two other
significant uncertainties. First, in the absence of a diagnostic test for BSE in live
animals, it was impossible to know which animals might be incubating the disease.
It could be statistically demonstrated, in the case of any individual animal at the
time of slaughter, that that animal was very unlikely to be incubating BSE. Second,
it was probable that not all parts of an infected animal might carry infectivity
sufficient to transmit the disease to other animals of its own or other species.

1305 The evidence disclosed a number of occasions on which lawyers in MAFF’s
Legal Department expressed concern as to whether precautionary measures which
were being proposed fell within the powers conferred by the legislation under which
they were to be introduced. We consider it desirable that legislation should clearly
empower Ministers to take precautionary measures in a situation where the
existence of a hazard is uncertain. We believe that there are areas where this may
not be the case. We have not attempted a detailed analysis of the law in these areas,
for this is not part of our task. We draw attention to them so that they may receive
further consideration.

Power to order the slaughter of animals

1306 Section 32(1) of the Animal Health Act gives the Minister power, if he thinks
fit, to order the slaughter of ‘any animal which is affected or suspected of being
affected with any disease to which this section applies, or has been exposed to the
infection of any such disease’.

1307 Mr MacGregor used this power when introducing the slaughter and
compensation scheme in August 1988. The primary reason why he did so was in
order to address what was considered to be the remote possibility that BSE was
transmissible to humans.                                                                267
FINDINGS AND CONCLUSIONS


         1308 MAFF lawyers expressed doubts as to whether s.32(1) could be used in these
         circumstances. We do not know whether these doubts were resolved or, if they
         were, on what basis. We consider that there was certainly scope for doubt as to the
         extent of the Minister’s powers under s.32(1), having particular regard to the fact
         that:

                i.    scientists considered it unlikely that BSE was transmissible to humans;
                      and
                ii.   BSE had not at that time been designated a zoonosis under S.29 of the
                      Act.

         1309 Consideration was given to a policy of slaughtering animals in the same herd
         as a BSE victim, or slaughtering the offspring of BSE victims, because of the
         possibility that BSE might be vertically or horizontally transmissible. Again we
         think that there would have been some doubt as to the power of the Minister to
         introduce such a policy under s.32(1) of the Act, having regard to the uncertainty as
         to the manner in which BSE might be transmitted.

         1310 An animal which was not showing clinical signs of BSE would not,
         ordinarily, be said to be ‘affected with the disease’. Furthermore, even if the word
         ‘affected’ in section 32(1) included pre-clinical infection, it would be difficult to say
         of any such animal that it was ‘suspected of being affected with BSE’, since
         statistically this would be highly improbable in the case of any individual animal.
         Nor is it clear that an animal could properly be described as ‘exposed to infection’
         in circumstances where it was uncertain whether transmission of infection was
         possible.

         Power to order the destruction of parts of an animal

         1311 Section 1 of the Animal Health Act 1981 gives Ministers power to make
         ‘such orders as they think fit . . . for the purpose of in any manner preventing the
         spread of disease’, and section 8 gives them power to make ‘such orders as they
         think fit’ for prohibiting and regulating the removal of ‘carcasses, fodder, litter,
         dung and other things’. Section 35(1) of the Act also gives Ministers power to order
         the seizure, and impose requirements for the destruction, burial, disposal or
         treatment, of ‘anything, whether animate or inanimate, by or by means of which it
         appears to them that any disease to which this subsection applies might be carried
         or transmitted’.

         1312 The powers under section 35(1) were used in 1991 to give MAFF the power
         to seize, destroy and dispose of the carcasses of animals suspected of having died
         from BSE. The powers under sections 1 and 8 were used to protect human health by
         ordering the destruction of milk from cows affected by BSE, after BSE had been
         designated a zoonosis.

         1313 These sections of the Animal Health Act are in very wide terms. The question
         arises of whether they could have been used to order the destruction of SBO as a
         precautionary measure to safeguard human health, whether through foodstuffs or
         any other consumer product. We consider that had such a course been adopted, a
         challenge might have been anticipated on the grounds that:
268
                                                                         LESSONS TO BE LEARNED


       i.    it was statistically highly unlikely that any individual animal was
             incubating the disease; and
       ii.   scientists believed it unlikely that tissues from an animal incubating the
             disease posed any risk to humans.

1314 We do not suggest that such a challenge would necessarily have succeeded.

Power to ban the use of material for specified purposes

1315 Apart from the slaughter and compensation policy, which related only to
cattle diagnosed as showing clinical signs of BSE, and the power to seize and
destroy carcasses of animals suspected of having died of BSE, the Government did
not order the compulsory destruction and removal from circulation of any animals,
parts of animals or material derived from or connected with animals which might
have been incubating or exposed to BSE. Instead, the Government adopted the
alternative approach of banning the use of potentially infective material for
particular purposes. Thus the ruminant feed ban prohibited the use of ruminant
protein in feed for ruminants; the human and animal SBO bans prohibited the use
of particular bovine tissues in food for human and animal consumption, and
subsequently prohibited the movement of MBM derived from SBO material to any
unlicensed destination; and MRM derived from bovine vertebral columns was
banned from use in human food. The question arises whether Ministers had
adequate powers to adopt the approach of banning suspect material for particular
purposes in the face of the uncertainties about BSE which we have outlined above.

1316 Under a range of different statutes, Ministers had power to take action to
block potential routes of transmission of animal diseases by imposing requirements
as to the manufacture, sale or supply of products which might incorporate animal
material. Thus:

   •   the Animal Health Act, the Food Act 1984 and its successor, the Food Safety
       Act 1990, gave the relevant Ministers power in certain circumstances to ban
       animals and animal tissues from incorporation in food for animal and human
       consumption;
   •   the Consumer Protection Act 1987 gave the Secretary of State for Trade and
       Industry power to make provisions for the purpose of securing that goods
       were safe, and for the purpose of securing that goods which were unsafe
       were not made available to persons generally;
   •   the Environmental Protection Act 1990 gave power to regulate the release of
       harmful substances into the environment; and
   •   the Medicines Act 1968 gave the licensing authorities power to impose
       requirements as to methods of manufacture or as to product ingredients as a
       condition of granting product licences for human and veterinary medicines.

1317 In the case of the powers granted by each of these statutes, questions were
liable to arise as to whether they empowered action on a precautionary basis in
circumstances where the existence of risk was not merely uncertain, but considered
very unlikely. Thus, when it was proposed to introduce the human SBO ban in June
1989, MAFF lawyers advised the administrators that ‘given that it is not possible to
                                                                                          269
FINDINGS AND CONCLUSIONS


         prove that the offal to be banned is in fact “unfit” for human consumption, it will be
         necessary to be able to justify the reasonableness of provisions made as to use’.109
         They recognised the possibility of a challenge to a ban introduced under the Food
         Act in order to protect humans from a risk which was far from established, and in
         fact considered to be remote.

         Legislative constraints in relation to medicines

         1318 The Food Act 1984 and the Food Safety Act 1990 contained powers to
         prohibit the sale or use of any specified substance or any substance of a specified
         class in or as food intended for sale for human consumption. As MAFF lawyers
         pointed out when the provisions of the human SBO ban were being considered, this
         power did not enable prohibition of the use of these substances in or in the
         production of medicines. The legislative scheme for regulating the safety of
         medicines was very different.

         1319 In granting or renewing any product licence under the licensing regime
         established by the Medicines Act, the licensing authorities could have made it a
         condition that material from BSE-affected cattle, and SBO from any cattle, should
         not be used in the manufacture of a product. However, it does not appear that the
         licensing authorities could have made this a general requirement to cover all human
         and veterinary medicinal products. They could only have acted on a case-by-case
         basis by including such a requirement in every licence for a product which might
         include such material, as and when an application was made for the grant or renewal
         of a product licence.

         1320 As for existing licences, the statutory power to suspend, revoke or vary a
         licence was subject to a requirement that the licence holder should be given notice
         of the intention to revoke or vary the licence and afforded an opportunity to appear
         before the relevant section 4 committee or to make representations in writing as to
         the proposed revocation or variation. While the licensing authority had power to
         suspend an individual licence with immediate effect in the interests of safety, such
         suspension could not exceed a period of three months pending consideration as to
         whether the licence should be varied or revoked, and the licence holder was entitled
         to appear before the relevant committee and to make representations on the
         matter.110

         1321 If, in response to BSE, the licensing authority had wished to use its statutory
         powers to ensure that UK bovine material was not used in the manufacture of
         medicinal products, it seems that it would have had to revoke or vary every relevant
         product licence (possibly after a suspension of up to three months), and in doing so
         it would have had to give each current licence holder or applicant the opportunity
         to appear before the relevant section 4 committee to argue against the proposed
         revocation or variation. This would have been an administrative nightmare. In these
         circumstances it is not surprising that the decision was taken to issue guidelines
         rather than attempt to use formal statutory powers.

         1322 We consider that it might be of value if licensing authorities had a statutory
         power under the Medicines Act to impose a general prohibition on the use of
         substances which are considered to be unsafe in the manufacture of any human and
         109
               YB89/6.12/3.1
270      110
               Section 29 and schedule 2, paras 1–14
                                                                        LESSONS TO BE LEARNED


veterinary medicines. We appreciate, however, that this suggestion may not be
compatible with a regulatory regime which is now governed by European law.

Legislative constraints in relation to cosmetics

1323 Cosmetics is another area where the regulatory regime is governed by
European law. The Cosmetic Products (Safety) Regulations 1989 give effect to the
1976 EC Cosmetics Directive. Little scope is left for independent regulatory action
by the UK Government, and effecting changes to European Regulations can be a
lengthy business.

1324 In these circumstances we were told that in practice the regulation of the
cosmetics industry operated on an informal and voluntary basis, under which
guidance was given to and implemented by the industry. This was the course
adopted in relation to BSE. It does not seem to us that this regulatory regime caters
satisfactorily for a situation such as the emergence of BSE.

General constraints of European law

1325 When a manufacturer of MRM sought judicial review of the Specified
Bovine Offal (Amendment) Order 1995, one of the arguments put forward was that
once definitive measures for a relevant outbreak of disease had been adopted by the
European Commission at the EU level, individual Member States were no longer
entitled to adopt unilateral measures to deal with the risks posed by the disease.

1326 The High Court granted leave to seek a judicial review of the Order, thereby
indicating that it considered the matter to be at least reasonably arguable. However,
the judicial review was abandoned after 20 March 1996, and so this argument was
not tested at the time. It may well remain open to those who object to actions taken
by the Government to deal with zoonoses generally, and BSE in particular, where
those actions go beyond EU measures taken under Directives 89/662/EEC and 90/
425/EEC.

1327 If the argument is correct, the consequences are worrying. First of all, it calls
into question the lawfulness of the Specified Bovine Offal (Amendment) Order
1995. The Government decided to act speedily to ban the use of bovine vertebral
columns in the manufacture of MRM on the advice of SEAC. We believe that such
action was clearly desirable in the interests of human health. However, this
important measure could have been open to challenge under European law, at least
until it was adopted by the Commission in July 1997 by Decision 97/534.

1328 The argument also has implications for the future handling of other zoonoses
or potential zoonoses. It suggests that in matters governed by the Directives we have
cited, the Government may not be able to take unilateral action in the event of a
reassessment of the risks associated with a particular disease outbreak.

1329 We understand that a similar point is currently before the European Court of
Justice. We expect that this issue will be reviewed by MAFF when the decision of
the Court is known. If, in the light of that decision, there remains any danger that
measures for the protection of human or animal health may be readily susceptible
to challenge, consideration will need to be given to steps to minimise this danger.      271
FINDINGS AND CONCLUSIONS


         Lessons

            •   Where an animal disease is identified, which could be transmitted to animals
                or humans via a range of possible routes, powers under UK and European
                law which enable Ministers to order the slaughter of animals, and the
                destruction of animal tissues or anything which might carry infection, should
                not be restricted merely because it cannot be established as a reasonable
                probability, as opposed to a mere possibility:
                i.    that the disease is transmissible; or
                ii.   that a particular animal may be infected by the disease in question; or
                iii. that particular organs or tissues in an animal may carry infection.
            •   Similarly, any powers under UK and European law which enable Ministers
                to adopt an alternative approach of banning the use of any substances for
                particular purposes in order to protect human or animal health should not be
                restricted merely because one or more of the matters referred to above cannot
                be established as a reasonable probability, as opposed to a mere possibility.
            •   Current medicines and consumer protection legislation should be reviewed
                with a view to giving the Government power to act swiftly and
                comprehensively to ban the use of any substances or processes which might
                pose a risk to human or animal health.
            •   The Government should review and clarify its powers under European law
                to introduce emergency measures for the protection of public and animal
                health in relation to outbreaks of disease where measures have previously
                been taken by the European Commission.

         The experience of vCJD victims and their families

         Commentary

         1330 Members of the families of 15 young victims of vCJD came to tell us of what
         they had experienced. Many more provided us with statements. The description of
         the clinical treatment of the disease that has been set out in Volume 8 does not fully
         bring home the horror of what in each case was a harrowing personal tragedy. It is
         particularly hideous to see young people struck down by a destructive neurological
         disease of the kind that more usually strikes those who have enjoyed something
         close to a full life-span.

         1331 The start of the nightmare is an inexplicable change of personality. A happy,
         outgoing and confident young person develops mood swings, depression and lapses
         of short-term memory. Worried parents or relatives consult their GP, who can find
         no clinical signs and prescribes an anti-depressant. As the symptoms worsen a
         referral to a psychiatrist follows.

         1332 The psychiatrist finds no sign of organic disease and treats the patient for
         psychiatric illness, sometimes as an inpatient in a psychiatric ward, where both the
         environment and the treatment are inappropriate. No improvement follows. For the
         victim and the relatives this is a time of acute anxiety, but worse is to follow.
272      Neurological symptoms supervene: pins and needles and pains in the limbs,
                                                                       LESSONS TO BE LEARNED


unsteadiness of gait, failures of muscle coordination. A referral is made to a
neurologist. A neurological condition is diagnosed – the nature of it may not be.
There are other conditions that have similar signs and symptoms to those of vCJD.

1333 Different tests are carried out, some invasive and unpleasant. Sometimes
vCJD is suspected, sometimes it is not. The symptoms worsen: speech difficulties,
impairment of intellect, involuntary movements, incontinence, progressive
immobility until the victim is bedridden. It becomes plain that there will be no
recovery.

1334 Some families want to care for their loved one at home until the end comes.
Others seek a suitable hospital or hospice. In either case their anxiety is that the
patient’s final days should be spent in a caring, secure and comfortable
environment.

1335 The victims of vCJD and their families have special needs. Degenerative
neurological diseases of the young are rare. The structure of the health service
makes no special provision for them. Hospital facilities for the elderly who are
terminally ill are seldom the place for young people. Hospices that care for those
whose days can be numbered may be reluctant to accept patients for whom it is
impossible to predict when the end will come.

1336 The evidence that we received showed widely varying standards of
management and care of victims of vCJD and of support for their families.

Lessons

1337 What is needed includes:

   •   as speedy as possible a diagnosis of vCJD;
   •   informed and sympathetic advice to relatives about the future course of the
       disease and the needs of the patient;
   •   speedy assistance for those who wish to care for the victim at home. Needs
       often include aids for the care of the disabled, modification to the home,
       financial assistance and respite care;
   •   a coordinated care package which addresses the needs of the victims and
       their families; and, if requested;
   •   a suitable institutional environment for a young person, incapacitated and
       terminally ill.

1338 It should occasion neither surprise nor individual criticism that these needs
were frequently not met in the early days of the disease. We are now able to look
back with hindsight. The lesson is clear: the needs of vCJD victims call for a
different approach by the health service and the social services departments of local
authorities.




                                                                                        273
FINDINGS AND CONCLUSIONS




274
Annex 1: Procedures adopted
by the BSE Inquiry
1339 In this annex we describe how we sought to achieve our aims of being
thorough, open and fair.



Thoroughness and openness

1340 At our preliminary hearing in January 1998 we asked anyone who thought
they had relevant evidence to contact the Secretary to the Inquiry.

1341 To assist us in understanding the evidence we would be hearing, we pursued
a course of education in order to acquire the necessary background knowledge.
We attended a series of lectures on topics including microbiology, epidemiology
and toxicology. We also went on a series of visits which we describe below.
Government Departments set up ‘Liaison Units’ to assist us. The first of many tasks
these Units undertook was to assemble a set of initial background documents which
we published as our Initial Background Documents (IBD) series of bundles.

1342 With the assistance of the Liaison Units, the Inquiry Secretariat identified
civil servants who appeared likely to have had an involvement with BSE and variant
CJD. These civil servants were then divided into two groups. Witnesses identified
as probably having only a peripheral involvement in matters of interest to the
Inquiry were initially asked to provide general information about the posts they held
and the nature of the dealings they had with BSE or vCJD between 1985 and
20 March 1996. Civil servants identified as probably playing a more central role
were asked to provide a thorough statement of the part they played, their
responsibilities as they understood them at the time, the information they received,
the actions and decisions they took and the reasons for them.

1343 A consultation document on our procedures was circulated in January 1998.
This explained that we would be seeking evidence from scientists, those who could
give evidence of fact relating to the period prior to the outbreak of BSE (including
evidence as to the manufacture of cattle feed and the rendering processes involved),
administrators, families of victims of vCJD, the farming industry and other
commercial interests, consumer representatives, former Ministers and others.
We invited people to suggest names of witnesses for the Inquiry. As the Inquiry
proceeded, we requested many individuals to provide supplemental statements,
clarifying evidence or addressing further issues. In total, we have published over
1,000 witness statements from over 630 different individuals.

1344 Many of those who played a more central role in events were invited to
participate in oral hearings. We heard oral evidence on 138 days. Each hearing was
in public and we tried to make the atmosphere at these hearings as informal as
possible. We permitted a live radio broadcast of our proceedings and television
cameras were permitted when witnesses were not giving evidence.                         275
FINDINGS AND CONCLUSIONS


         1345 The witness statements provided by those scheduled to give oral evidence
         were published prior to the relevant hearing. We invited comments from relevant
         individuals on the content of these statements, and where appropriate these were
         raised with the witness at the oral hearing.

         1346 We took full advantage of information technology to make transcripts of
         these hearings available over the Internet, usually within a few hours of the witness
         giving evidence. We also provided free access to all witness statements, timetables,
         and background information on our website. This website was extremely popular.
         Over 160,000 witness statements and almost 86,000 transcripts were accessed from
         our website, which received over 1.5 million page requests. In April 1998 the
         Inquiry was awarded a Freedom of Information Award by the Campaign for
         Freedom of Information for its innovative use of the Internet. Modern technology
         was used in other ways – during one hearing we discussed epidemiological evidence
         via a video link with scientists in Canada and New Zealand.

         1347 A less glamorous, but essential, part of the process of the Inquiry was the
         analysis of documentation. Members of the Secretariat went in teams to
         Government Departments to conduct a trawl of their files. Most information came
         from the Ministry of Agriculture, Fisheries and Food and the Department of Health.
         Other Departments which supplied information included the Health and Agriculture
         Departments in Wales, Scotland and Northern Ireland. These teams examined about
         3,000 files, and identified approximately 75,000 pages of documents as being of
         interest to the Inquiry. Documents were also supplied to the Inquiry by companies,
         trade associations, scientists, and other individuals. Analysis of the documents we
         received, and requests for further material on points arising from them, was a
         continuing process.

         1348 Our Inquiry was unusual in beginning oral hearings before completion of the
         task of finding and collating relevant documentary evidence. In the early stages we
         were necessarily reliant on witnesses to point us to relevant material. As our
         documentary trawl proceeded we were able to check whether relevant avenues of
         investigation had been sufficiently covered.

         1349 Throughout the Inquiry, we sought to make available to the public the
         contemporaneous documents we considered relevant to our work. A reference room
         containing a full set of all materials was available for use by the press and public.
         In addition to all published witness statements and transcripts of oral evidence,
         these included:

                    •   a mass of shorter documents (such as letters and minutes) arranged in
                        chronological order (the Year Book, or YB, series). This series grew
                        considerably during the Inquiry and ended up with nearly 16,000
                        separate documents;
                    •   bulky materials, such as book chapters and reports (the Materials, or
                        M, series);
                    •   articles from scientific journals, telling much of the scientific story
                        (the Journal series); and
                    •   the selection of ‘initial background documents’ provided by the
                        Liaison Units referred to above (the IBD series).
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1350 In addition to learning about scientific topics, we went on several visits.
These included tours of an abattoir, a rendering plant, a Veterinary Investigation
Centre, and two farms in Wales. We went to Weybridge to visit the Central
Veterinary Laboratory and to Edinburgh to visit the CJD Surveillance Unit and the
Institute for Animal Health’s Neuropathogenesis Unit. We also visited a livestock
market in Northern Ireland to see the cattle-tracking system in operation and were
shown the Animal Health Computerised Traceability System at the headquarters of
the Department of Agriculture for Northern Ireland.

1351 Early in the Inquiry, we issued a number of working documents, including a
glossary, a dramatis personae and a time-line setting out some of the main events in
chronological order. More ambitiously, in December 1998 the Inquiry began to
publish draft factual accounts (DFAs) of aspects of the history of BSE and vCJD.
The DFAs were placed on our website and sent to witnesses. They were intended to
help us clarify the overall picture and to enable all those who were concerned or
interested to draw attention to any errors or significant omissions in the drafts. The
DFAs were not definitive. We recognised prior to their publication that they could
contain errors or omissions. We stressed that DFAs should be treated as no more
than working documents, intended to set out relevant evidence in a neutral manner.

1352 Following the publication of the first tranche of DFAs, some witnesses raised
concerns with us. They were very concerned that substantial amendment was
required and that the original drafts were in places inaccurate or misleading. After
considering what they said, we produced revised versions of many of the DFAs,
taking account of the comments and additions which witnesses had, as we expected,
proposed. The revised versions (RFAs) produced with the help of witnesses and
others were considerably improved and this assisted us greatly in establishing the
course of events. Further DFAs were published as the Inquiry proceeded. Updates
to both the DFAs and RFAs were produced in some cases to deal with comments
and to draw attention to further relevant evidence.

1353 We believe that the DFAs, RFAs and updates assisted many of those who
were taking an interest in the Inquiry’s work. We could not produce DFAs for all
aspects of the story, but where they were produced, they collated a mass of relevant
information in a way which enabled it to be digested and reviewed. They also
enabled witnesses to refresh their memory of events and identify evidence upon
which they wished to comment.

1354 In June 1998 we published a document setting out our understanding of
government structures for scientific research. This was followed in 1999 by
discussion papers inviting comments on issues relating to the role of the advisory
committees, particularly SEAC, and on epidemiology. When the hearing of oral
evidence drew to a close, we issued a more general invitation to supply any further
comments anyone wished to make.

1355 In all we received over 11,700 letters, e-mails and faxes in relation to our
work during the course of the Inquiry.




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FINDINGS AND CONCLUSIONS


         Fairness

         1356 We gave an indication of the procedures we proposed to adopt at our
         Preliminary Hearing in January 1998. We considered it important to receive
         comments on our proposed procedures and therefore set these out in more detail in
         a consultation document issued by the Inquiry Secretariat at the end of that month.
         After taking account of comments on the consultation document, we issued a
         statement of our intended procedures.

         1357 Further statements on our procedures in relation to later aspects of our work
         were issued during the course of the Inquiry. We did not regard our Statements on
         Procedures documents as an inflexible account of our procedures. We were
         prepared to, and did, vary our procedures in the light of representations and
         changing circumstances. The Statements were intended merely as a helpful guide to
         those participating in and following our work. Anyone wishing to learn more about
         the detail of the procedures we adopted may wish to refer to those Statements.111

         1358 As we had proposed in our original consultation document, we adopted a
         two-phase approach to our work. The first phase, ‘Phase 1’, was confined to
         fact-finding. In ‘Phase 2’, we moved on to examine questions which required
         clarification, issues on which there were conflicts of evidence, and potential
         criticisms which might be made of individuals. This description seems to have
         given rise to a misunderstanding: some thought that there would be no, or no
         substantial, further fact-finding in Phase 2. In a revised Statement on Procedures for
         Phase 2, we made it clear that during Phase 2 we would continue to seek further
         evidence of the facts as we thought appropriate having regard to our
         Terms of Reference.

         1359 As with Phase 1, our procedures for Phase 2 were the subject of a
         consultation process. Our consultation document explained that the Secretariat
         would write to individuals identifying potential criticisms. (Letters of this kind were
         recommended by the Royal Commission on Tribunals of Inquiry chaired by Lord
         Justice Salmon in 1966,112 and are known as ‘Salmon letters’.) All who received
         such letters would be asked to respond in writing and would be entitled (if they
         wished) to answer any remaining concerns at an oral hearing.

         1360 A number of concerns were expressed by witnesses. In particular, concerns
         were expressed in relation to the confidentiality of the potential criticisms we
         wished to explore with witnesses and of the response of those witnesses. We
         concluded that we could not guarantee to keep potential criticisms or the replies
         confidential. We stated in the relevant Statement of Procedures document that
         neither our letter notifying our concerns nor the response from the witness would
         be treated as documents over which the individual concerned had a right of
         confidentiality. Material from either document could be disclosed where such
         disclosure was considered necessary for the fair and proper conduct of the Inquiry.

         1361 Those facing potential criticism are naturally concerned to be aware of any
         information which might be in conflict with the potential criticism. We used DFAs,
         RFAs and updates to ensure that witnesses were kept informed of relevant evidence.
         Our Secretariat undertook to consider whether there was any evidence of this kind
         111
               Inquiry Announcements bundle 2, tabs 1, 10, 15 and 23 (IA2 tabs 1, 10, 15 and 23)
278      112
               Cmnd 3121
                                                  : PROCEDURES ADOPTED BY THE BSE INQUIRY


which had not been referred to in a DFA (or comments on a DFA) sent to an
individual facing potential criticism, and to inform that person of any such evidence.
We added in our Statement of Procedures for Phase 2 that if material were supplied
to the Inquiry in confidence, and the confidentiality were maintained, we would pay
no regard to anything in that material supporting a potential criticism. If confidential
information could reasonably enable an individual to contradict an issue arising out
of a potential criticism, we would discuss with that individual what procedures
should be adopted to deal with the material.

1362 In order to ensure that all relevant information was in the public domain, we
requested that responses to potential criticisms be accompanied by a statement for
the purpose of publication, which set out all factual matters on which the recipient
of a letter of potential criticism wished to rely in addition to any evidence already
provided in material published by the Inquiry. Not all those involved followed this
course. The Inquiry Secretariat had to devote substantial resources to going through
responses, identifying new evidence of fact and putting forward a proposed
statement for publication. On occasion, to ensure that new evidence of fact was
put in the public domain, it was necessary for the Inquiry to publish a ‘statement
of information provided by a witness’ in the absence of approval from the
relevant witness.

1363 At first, we had envisaged a ‘final stage’ of our Inquiry when those
participating in the Inquiry would be given a relatively short time in which to make
written submissions on relevant aspects. As Phase 2 progressed, we thought it
would be more useful, once the main evidence relevant to a particular area was
complete, to write to those facing potential criticism identifying anything which no
longer needed to be pursued, and suggesting a time within which additional
comments on extant potential criticisms should be supplied.

1364 We also concluded in November 1999 that the time had come to reduce the
burden on Inquiry resources and change our procedures. It seemed to us that new
factual evidence in Additional Comments would not necessarily require a new
statement for publication. Our Statement on Procedures for Additional Comments
said that we did not propose to publish any Additional Comments we received. We
recognised that it was possible that such comments could contain fresh evidence on
matters of fact tending to contradict an extant potential criticism, and proposed that
in such circumstances we would make arrangements to ensure that anyone notified
of the potential criticism in question was informed. This appeared uncontroversial,
but when Additional Comments were submitted, there were some who took issue
with this. In contrast to the stance adopted at the time of receipt of Salmon letters,
a number of those facing potential criticisms said that they wanted their Additional
Comments to be published. We considered, in each case, whether we should depart
from the procedures we had envisaged for Additional Comments, but concluded
that we should not.




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      Annex 2: Individual criticisms
      1365 We have given anxious consideration to whether individuals should be
      criticised in relation to their response to BSE and vCJD. It is a necessary part of our
      Terms of Reference – but it is not the most important. We would put the lessons
      to be learnt from BSE at the forefront. Nevertheless, we recognise that the
      identification of individual criticisms is an important part of our remit, and we have
      therefore set out this information in this annex. We draw attention to the fact that
      the areas where we have criticised individuals are relatively few. We have listed the
      individual criticisms below so that their nature and limitations can be clearly seen.
      Cross-references are given to locations in the Report where precise details will be
      found, along with information needed to set the matter in context.

      1366 The Report comments on the response of Government Departments and
      others, and identifies inadequacies. The mere fact that a response on a particular
      issue was inadequate, or that some part of the response was regrettable or
      unfortunate, does not mean that individuals are criticised. Only on those occasions
      when we consider that somebody should have acted differently, in the light of
      knowledge at the time, have we criticised that individual. In this volume we point
      out that these criticisms must be set in context. At this point we would invite the
      reader to turn to paragraphs 1245–1259 in Chapter 13, for what is said there is
      highly relevant to the remainder of this annex. If those criticised were misguided,
      they were nonetheless acting in accordance with what they conceived to be the
      proper performance of their duties. The overall value of the contributions that they
      have made should not be lost from view. Those who were most active in addressing
      the challenges of BSE are those who are most likely to have made mistakes. It is in
      that context that the Report makes the following criticisms:



      The early years

         •   Dr Watson should have sought the assistance of the NPU from the outset
             (Volume 1, paragraph 175; Volume 3, paragraphs 2.137–2.148).
         •   Dr Watson and Dr Williams should have urged the merits of publication of
             information about BSE, and Mr Rees should have permitted it (Volume 1,
             paragraphs 176–178; Volume 3, paragraphs 2.137–2.194).
         •   Mr Rees should have permitted publication of a proposed article which
             compared BSE with scrapie (Volume 1, paragraph 179; Volume 3,
             paragraphs 2.137–2.194).
         •   Mr Meldrum should have ensured that proper consideration was given to the
             impact of cross-contamination on the ruminant feed ban (Volume 1,
             paragraph 214; Volume 3, paragraphs 4.116–4.157).
         •   Dr Watson, Mr Rees and Mr Cruickshank should have sought to involve the
             Department of Health in consideration of the risk to human health from BSE
             prior to March 1988 (Volume 1, paragraph 234; Volume 3, paragraphs
             5.114–5.159).
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                                                                     : INDIVIDUAL CRITICISMS


The Southwood Working Party

  •   The Working Party should have made it plain that the section of their report
      dealing with epidemiology had been provided by Mr Wilesmith and was
      based on data which they had not been able to review (Volume 1, paragraph
      260; Volume 4, paragraph 10.28).
  •   The Working Party should have made it clear that, in describing the risk as
      remote, they were intending to indicate that steps should be taken to reduce
      the risk so that it was as low as reasonably practicable (Volume 1,
      paragraph 272; Volume 4, paragraphs 10.35 and 10.36).
  •   The Working Party should have pointed out the possible risk to the human
      food chain from cattle incubating BSE, and pointed out the need to consider
      identifying such steps as were reasonably practicable to prevent potentially
      infective tissue being eaten by humans generally, not just babies (Volume 1,
      paragraphs 273 and 275; Volume 4, paragraphs 10.53–10.82).
  •   The Working Party should not have allowed their Report to give the reader
      a false impression of their assessment of the risk relating to medicinal
      products and occupational exposure (Volume 1, paragraphs 278–279;
      Volume 4, paragraphs 10.83–10.109).



Protection of animal health, 1989–96

  •   In May 1990 Mr Gummer was informed of a cat that had come down with
      FSE, and understood from Mr Meldrum that there was no likely connection
      between this cat and BSE. Mr Meldrum should not have given Mr Gummer
      that impression (Volume 1, paragraphs 363 and 650; Volume 6, paragraphs
      4.687–4.702).
  •   While we do not say that Mr Meldrum and Mr Lowson should have
      identified all the answers to the considerable problems posed by the ban on
      SBO in animal feed, they should at least have identified that serious
      problems existed (Volume 1, paragraphs 415–416; Volume 5, paragraphs
      4.789–4.853).



Protection of human health, 1989–96

  •   Sir Donald Acheson and Mr Clarke should have ensured that the Department
      of Health reviewed the Southwood Report, and in particular considered the
      question why, if offal was not safe for babies, it was nevertheless safe for
      adults (Volume 1, paragraphs 542 and 550; Volume 6, paragraphs 3.63–
      3.134).
  •   Mrs Attridge should have pursued the question ‘Why should we take action
      on baby food and not on hamburgers?’; Mr Cruickshank should have taken
      steps to find out why the Southwood Report drew a distinction between
      babies and others and between clinical and subclinical animals; and
                                                                                      281
FINDINGS AND CONCLUSIONS


                Mr Meldrum should have pursued these questions (Volume 1, paragraph
                552; Volume 6, paragraphs 3.102–3.116).
            •   Mr Andrews should have raised with Mr MacGregor the need to have an
                answer to the question why action should be taken on baby food and not
                other food, and Mr MacGregor himself should have seen that the question
                was pursued (Volume 1, paragraph 553; Volume 6, paragraphs 3.63–3.124).
            •   Mr MacGregor is commended for introducing the SBO ban, but he should
                not have agreed to a presentation of that ban which played down its
                importance as a protection for human health (Volume 1, paragraph 569;
                Volume 6, Chapter 3, paragraphs 3.358–3.320).
            •   Mr Colin Maclean was responsible for inaccurate statements to the public in
                material prepared on behalf of the MLC in 1990. These statements, which
                exaggerated the safety of beef and suggested that precautions that had been
                put in place were unnecessary, were capable of misleading and Mr Maclean
                should have been more careful (Volume 1, paragraphs 645 and 654; Volume
                6, Chapter 4, paragraphs 4.729–4.743).
            •   Sir Donald Acheson should have appreciated that his public statement about
                the cat was likely to give false reassurance about the possibility that BSE
                might be transmissible to humans; the possibility of BSE having being
                transmitted to a cat was cause for concern and needed to be investigated by
                scientists (Volume 1, paragraph 660; Volume 6, Chapter 4, paragraphs
                4.170–4.724).
            •   Dr Metters told colleagues they should avoid the implication that ‘somehow
                the disease poses a risk to human health’; he should not have adopted this
                approach (Volume 1, paragraph 672; Volume 6, Chapter 4, paragraphs
                4.725–4.728).
            •   Sir Kenneth Calman should not have made statements in 1993 and 1995
                without ensuring that they fairly reflected his appraisal of the risk posed by
                BSE (Volume 1, paragraphs 721–724 and 770; Volume 6, paragraphs 5.337–
                5.349 and 6.341–6.351).
            •   Dr Kendell should not have made a public statement in 1995 which did not
                make it plain that the safety of eating beef was dependent on strict
                compliance with the precautionary measures introduced by the Government
                (Volume 1, paragraph 773; Volume 9, paragraphs 11.40–11.53).
            •   Mr Colin Maclean, as Director-General of the MLC, was responsible for the
                vigorous advertising campaign that the MLC ran in 1995. In the course of
                that campaign there were occasions when hyperbole displaced accuracy.
                Mr Maclean should not have allowed this (Volume 1, paragraph 781;
                Volume 6, paragraphs 6.370 and 6.354–6.377).
            •   Mr Colin Maclean sent Dr Kimberlin a list of model answers which the MLC
                would have liked SEAC to give to questions which Mr Hogg had posed to
                the Committee. Dr Kimberlin was both a consultant to the MLC and a
                member of SEAC. Mr Maclean should not have asked Dr Kimberlin to
                provide this assistance; Dr Kimberlin should have told the members of
                SEAC of the request that the MLC had made (Volume 1, paragraphs 784–
                788; Volume 6, paragraphs 7.5–7.52).
282
                                                                    : INDIVIDUAL CRITICISMS


  •   Dr Wight sent minutes to Sir Kenneth Calman of SEAC’s meetings on
      5 January and 1 February 1996 which were inadequate in certain respects.
      Her January minute should have communicated the concerns expressed at
      the SEAC meeting by Dr Will. Her minute of the February meeting should
      have communicated the concerns expressed by Professor Pattison and
      Professor Collinge (Volume 1, paragraphs 798–800 and 805; Volume 6,
      paragraphs 7.100–7.107 and 7.160–7.164).
  •   Mr Eddy circulated a minute about the SEAC meeting on 1 February to
      Mr Hogg, Mrs Browning, Mr Packer, Mr Carden and Mr Meldrum.
      He should have included a clear warning of the concerns that had been
      expressed about the young cases of CJD and the possibility that they might
      prove to be linked to BSE (Volume 1, paragraph 804; Volume 6, paragraphs
      7.139–7.159).
  •   Despite the shortcomings in Mr Eddy’s minute, on reading that minute
      Mr Hogg and Mrs Browning should have sought to discuss its implications
      with Mr Packer, Mr Carden and Mr Meldrum. Similarly, on reading that
      minute, those officials, after discussion among themselves, ought to have
      raised its implications with Mrs Browning and Mr Hogg. Each of these five
      individuals should have considered the action that might be required should
      the scientists advise that BSE had probably been transmitted to humans, and
      they should have recognised the need for MAFF and DH to address the
      implications in conjunction, for example by seeking the views of
      Sir Kenneth Calman and by discussion between Mr Hogg and Mr Dorrell
      (Volume 1, paragraph 837; Volume 6, paragraphs 7.390–7.482).
  •   When Sir Kenneth Calman and Dr Metters received Dr Wight’s minute
      about SEAC’s meeting of 1 February 1996, albeit that it was couched in
      sedative terms, they should have initiated discussions with MAFF officials
      to discuss the implications of the new evidence and Sir Kenneth should have
      alerted Mr Dorrell (Volume 1, paragraph 842; Volume 6, paragraphs 7.390–
      7.482).
  •   Mr M B Baker and, to a lesser degree, Mr Jacobs should have taken steps to
      avoid the delay that occurred during parts of 1991 and 1992, in circulating
      advice to schools about dissecting bovine eyeballs (Volume 1, paragraph
      1045; Volume 6, paragraphs 9.141–9.151).



Medicines and cosmetics

  •   Dr Gerald Jones was responsible for deciding the priority to be accorded to
      BSE in relation to other work within Medicines Division and setting in hand
      appropriate action. He should have asked for the paper for the Biologicals